The following data is part of a premarket notification filed by American Carolina Stamping with the FDA for A.c.s. Suture Removal Kit.
| Device ID | K915827 |
| 510k Number | K915827 |
| Device Name: | A.C.S. SUTURE REMOVAL KIT |
| Classification | Suture Removal Kit |
| Applicant | AMERICAN CAROLINA STAMPING P.O. BOX 1079 Etowah, NC 28729 |
| Contact | Steve Mcnabb |
| Correspondent | Steve Mcnabb AMERICAN CAROLINA STAMPING P.O. BOX 1079 Etowah, NC 28729 |
| Product Code | MCZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-30 |
| Decision Date | 1992-12-08 |