K052992 is an FDA 510(k) clearance for the CONMED LINVATEC INSTRUMENT STERILIZATION TRAY. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on October 16, 2006, 356 days after receiving the submission on October 25, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K052992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 2005 |
| Decision Date | October 16, 2006 |
| Days to Decision | 356 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |