SOFSILK
Suture, Nonabsorbable, Silk
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Sofsilk.
Pre-market Notification Details
| Device ID | K964581 |
| 510k Number | K964581 |
| Device Name: | SOFSILK |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-15 |
| Decision Date | 1997-01-16 |
| Summary: | summary |
Trademark Results [SOFSILK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFSILK 74002125 1661283 Live/Registered |
UNITED STATES SURGICAL CORPORATION 1989-11-16 |
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