The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Suture Retention Clamp.
| Device ID | K771554 |
| 510k Number | K771554 |
| Device Name: | SUTURE RETENTION CLAMP |
| Classification | Retention Device, Suture |
| Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KGS |
| CFR Regulation Number | 878.4930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-12 |
| Decision Date | 1977-09-02 |