K883578 is an FDA 510(k) clearance for the S 21 INSTRUMENT STAND. This device is classified as a Tray, Surgical, Needle (Class I - General Controls, product code FSH).
Submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on September 13, 1988, 22 days after receiving the submission on August 22, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K883578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1988 |
| Decision Date | September 13, 1988 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FSH — Tray, Surgical, Needle |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |