K812562 is an FDA 510(k) clearance for the SURGICAL RETRACTOR & ELASTIC STAYS, DISP. This device is classified as a Hook, Surgical, General & Plastic Surgery (Class I - General Controls, product code GDG).
Submitted by Humboldt Products (Mchenry, US). The FDA issued a Cleared decision on October 2, 1981, 24 days after receiving the submission on September 8, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K812562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1981 |
| Decision Date | October 02, 1981 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDG — Hook, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |