K896383 is an FDA 510(k) clearance for the DISPOSABLE EXTERNAL CLAMPS. This device is classified as a Dissector, Surgical, General & Plastic Surgery (Class I - General Controls, product code GDI).
Submitted by Galenica Enterprises, Inc. (Quebec Canada J7e 4h7, CA). The FDA issued a Cleared decision on December 6, 1989, 30 days after receiving the submission on November 6, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K896383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1989 |
| Decision Date | December 06, 1989 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDI — Dissector, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |