K891894 is an FDA 510(k) clearance for the ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE. This device is classified as a Elevator, Surgical, General & Plastic Surgery (Class I - General Controls, product code GEG).
Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on April 12, 1989, 19 days after receiving the submission on March 24, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K891894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1989 |
| Decision Date | April 12, 1989 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEG — Elevator, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |