COLS® FIXATION SYSTEM
Fastener, Fixation, Nondegradable, Soft Tissue
FOURNITURES HOSPITALIERES INDUSTRIE
The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Cols® Fixation System.
Pre-market Notification Details
| Device ID | K120740 |
| 510k Number | K120740 |
| Device Name: | COLS® FIXATION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Contact | Patricia Donnard |
| Correspondent | Patricia Donnard FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-12 |
| Decision Date | 2013-03-05 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661489661426 | K120740 | 000 |
| 03661489661419 | K120740 | 000 |
| 03661489661389 | K120740 | 000 |
| 03661489661372 | K120740 | 000 |
| 03661489661365 | K120740 | 000 |
Trademark Results [COLS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COLS 85905739 4760757 Live/Registered |
Creative Dill LLC 2013-04-16 |
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