Case Medical 510k

510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173259

510 (k) Number. K173259. Device Name. Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories. Applicant. Case Medical, Inc. 19 Empire Blvd. South Hackensack,...

FDA 510k Certifications - Case Medical

https://casemed.com/index.php/fda-510k-certifications

Case Medical is a U.S. manufacturer of high quality, cost effective, sustainable products for instrument processing, including SteriTite® universal containers. FDA 510k Certifications …

Case Medical

https://casemed.com/

Case Medical, Inc. (“Case Medical”) is a U.S. manufacturer of high quality, cost effective instrument processing products and services. We were founded in 1992 as a supplier of …

A new 510k… And a behind the scenes peek at Case Medical

https://casemed.com/index.php/resources/blog/item/102-a-new-510k-and-a-behind-the-scenes-peek-at-case-medical

Understanding more about vertical integration in manufacturing will help you see why Case Medical is the right supplier for your facility. We have FDA 510k for our SteriTite® …

Premarket Notification 510(k) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

Search the Releasable 510(k) Database | FDA

https://www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database

You can search the releasable 510 (k) database by Panel, 510 (k) number, Product code or Device name. A search query will produce information from the database in the following …

Class I and Class II Device Exemptions | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions

A device may be exempt from 510 (k) requirements if the FDA determines that a 510 (k) is not required to provide reasonable assurance of safety and effectiveness …

510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed …

510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K991206

510 (k) Premarket Notification Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics …

510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K050293

powered laser surgical instrument. 22. 510 (k) Number. K050293. Device Name. FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: …