The following data is part of a premarket notification filed by Surgical Specialties Corporation with the FDA for Look Ptfe Suture.
| Device ID | K160744 |
| 510k Number | K160744 |
| Device Name: | LOOK PTFE Suture |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Applicant | Surgical Specialties Corporation Corredor Tijuana-Rosarito 2000, #24702-B Ejido Francisco Villa Tijuana, MX 22235 |
| Contact | Karen Sanchez |
| Correspondent | Karen Sanchez Surgical Specialties Corporation Corredor Tijuana-Rosarito 2000, #24702-B Ejido Francisco Villa Tijuana, MX 22235 |
| Product Code | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-17 |
| Decision Date | 2016-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782023513 | K160744 | 000 |
| 10848782033222 | K160744 | 000 |
| 10848782033239 | K160744 | 000 |
| 10848782033246 | K160744 | 000 |
| 00848782033256 | K160744 | 000 |
| 10848782033260 | K160744 | 000 |
| 10848782033277 | K160744 | 000 |
| 10848782023438 | K160744 | 000 |
| 10848782023445 | K160744 | 000 |
| 10848782023469 | K160744 | 000 |
| 10848782023452 | K160744 | 000 |
| 10848782023476 | K160744 | 000 |
| 10848782023483 | K160744 | 000 |
| 10848782023490 | K160744 | 000 |
| 10848782023506 | K160744 | 000 |
| 10848782033215 | K160744 | 000 |