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 |