K821921 is an FDA 510(k) clearance for the STAND, SURG. INSTRUMENT & DRESSING. This device is classified as a Tray, Surgical, Needle (Class I - General Controls, product code FSH).
Submitted by Emerson-Sack-Warner Corp. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1982, 31 days after receiving the submission on June 29, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K821921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1982 |
| Decision Date | July 30, 1982 |
| Days to Decision | 31 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 |