The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Smith & Nephew Suture Lok.
| Device ID | K991500 |
| 510k Number | K991500 |
| Device Name: | SMITH & NEPHEW SUTURE LOK |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Sigi Caron |
| Correspondent | Sigi Caron SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-29 |
| Decision Date | 1999-07-14 |
| Summary: | summary |