The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Conmed Linvatec Instrument Sterilization Tray.
| Device ID | K052992 |
| 510k Number | K052992 |
| Device Name: | CONMED LINVATEC INSTRUMENT STERILIZATION TRAY |
| Classification | Wrap, Sterilization |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Elizabeth Paul |
| Correspondent | Elizabeth Paul CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-25 |
| Decision Date | 2006-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854040222 | K052992 | 000 |
| 20845854040246 | K052992 | 000 |
| 30845854018785 | K052992 | 000 |