K823888 is an FDA 510(k) clearance for the 3M FRASCIA STAPLING SYSTEM. This device is classified as a Applier, Staple, Surgical, (Class I - General Controls, product code GEF).
Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on January 9, 1983, 13 days after receiving the submission on December 27, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K823888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1982 |
| Decision Date | January 09, 1983 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEF — Applier, Staple, Surgical, |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |