The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Conmed Linvatec Presto Preloaded With One Or Two #2 Hi-fi Sutures.
| Device ID | K092898 |
| 510k Number | K092898 |
| Device Name: | CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2009-10-19 |
| Summary: | summary |