The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Modification To: Modified Uss Polypropylene Suture.
| Device ID | K050947 |
| 510k Number | K050947 |
| Device Name: | MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Sharon L Murphy |
| Correspondent | Sharon L Murphy UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-15 |
| Decision Date | 2005-06-01 |
| Summary: | summary |