The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Video Extended Length Tray (plastic - Radel), Video Tray Single Level (plastic - Radel), Video Arthroscope Tray (plastic.
| Device ID | K133116 |
| 510k Number | K133116 |
| Device Name: | VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | CONMED CORPORATION 134 FLANDERS ROAD Westborough, MA 01581 |
| Contact | Nancy Gertlar |
| Correspondent | Nancy Gertlar CONMED CORPORATION 134 FLANDERS ROAD Westborough, MA 01581 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854040208 | K133116 | 000 |
| 20845854040215 | K133116 | 000 |
| 20845854040192 | K133116 | 000 |
| 20845854040185 | K133116 | 000 |