The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Tenolig.
| Device ID | K060367 |
| 510k Number | K060367 |
| Device Name: | TENOLIG |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Contact | Christine Quendez |
| Correspondent | Christine Quendez FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-08-09 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TENOLIG 79003438 3029322 Dead/Cancelled |
FOURNITURES HOSPITALIERES INDUSTRIE 2004-06-11 |