The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Ultrabraid Suture.
| Device ID | K041216 |
| 510k Number | K041216 |
| Device Name: | SMITH & NEPHEW ULTRABRAID SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Denise Lima |
| Correspondent | Denise Lima SMITH & NEPHEW, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-10 |
| Decision Date | 2004-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554034875 | K041216 | 000 |
| 23596010511946 | K041216 | 000 |
| 03596010547675 | K041216 | 000 |
| 03596010547682 | K041216 | 000 |
| 03596010587657 | K041216 | 000 |
| 03596010587664 | K041216 | 000 |
| 20885554034848 | K041216 | 000 |
| 20885554034855 | K041216 | 000 |
| 00885554034868 | K041216 | 000 |
| 23596010511939 | K041216 | 000 |