K951231 is an FDA 510(k) clearance for the ORTHOPEDIC PACKS. This device is classified as a Suture, Absorbable, Synthetic (Class II - Special Controls, product code GAN).
Submitted by Sterile Concepts, Inc. (Richmond, US). The FDA issued a Cleared decision on December 1, 1995, 256 days after receiving the submission on March 20, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4830.
| 510(k) Number | K951231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1995 |
| Decision Date | December 01, 1995 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAN — Suture, Absorbable, Synthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4830 |