The following data is part of a premarket notification filed by Smith & Newphew, Inc with the FDA for Smith & Newphew Ultrabraid Ii Suture.
| Device ID | K101377 |
| 510k Number | K101377 |
| Device Name: | SMITH & NEWPHEW ULTRABRAID II SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SMITH & NEWPHEW, INC 150 MINUTEMAND ROAD Andover, MA 01810 |
| Contact | Christina Flores |
| Correspondent | Christina Flores SMITH & NEWPHEW, INC 150 MINUTEMAND ROAD Andover, MA 01810 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-17 |
| Decision Date | 2011-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885554017650 | K101377 | 000 |