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510(k) Premarket Notification - Food and Drug …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=k100893
    FDA Home Medical Devices Databases 510 (k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards CFR Title 21 | Radiation …

510(k) Premarket Notification - accessdata.fda.gov

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=k040563
    FDA Home Medical Devices Databases 510 (k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards CFR Title 21 | Radiation …

www.accessdata.fda.gov

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn_template.cfm?id=k110304
    SANDSTONE MEDICAL TECHNOLOGIES LLC: 105 CITATION COURT: BIRMINGHAM, AL 35209 Applicant Contact: MARK ROHRER: Correspondent: SANDSTONE MEDICAL …

Sandstone Medical Technologies L L C FDA Filings

    https://fda.report/Company/Sandstone-Medical-Technologies-L-L-C
    Sandstone Medical Technologies L L C FDA Filings This page includes the latest FDA filings for Sandstone Medical Technologies L L C. Currently, you will find the latest 100 …

Address: Sandstone Medical Technologies LLC FEB …

    https://www.accessdata.fda.gov/cdrh_docs/pdf8/K082407.pdf
    Applicant: Sandstone Medical Technologies, LLC Address: Sandstone Medical Technologies LLC FEB -3 2009 516 Scott Street Homewood, AL 35209 USA Contact …

Cortex Co2 / Er:yag Laser System 510(k) FDA Premarket …

    https://fda.report/PMN/K110897
    SANDSTONE MEDICAL TECHNOLOGIES, LLC 105 CITATION COURT Homewood, AL 35209 : Contact: Mark Rohrer: Correspondent: Mark Rohrer SANDSTONE MEDICAL …

Polaris Q-switch Ruby System 510(k) FDA Premarket Notification …

    https://fda.report/PMN/K121162
    SANDSTONE MEDICAL TECHNOLOGIES, LLC 105 CITATION COURT Homewood, AL 35209 : Contact: Mark Rohrer: Correspondent: Mark Rohrer SANDSTONE MEDICAL …

FDA Permits Marketing of New Device Designed to …

    https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-device-designed-reduce-sleep-disturbance-related-nightmares-certain-adults
    The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along …

MAUDE Adverse Event Report: SANDSTONE MEDICAL …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3329780
    I had a sandstone fraxel laser treatment matrix fractional co 2 laser. I went in to have a very easy simple fraxel laser and the dr and the machine have caused severe burn to my …

Sandstone to Stop Imports | News & Features | Jun 2008 …

    https://www.photonics.com/Articles/Sandstone_to_Stop_Imports_/a34210
    Sandstone Medical Technologies LLC, a Birmingham-based producer of new and reconditioned lasers used in medical and cosmetic applications, said it will also take …



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