K820290 is an FDA 510(k) clearance for the SELF RETAINING RETRACTOR FOR HAND SURG. This device is classified as a Retractor (Class I - General Controls, product code GAD).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1982, 30 days after receiving the submission on February 3, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K820290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1982 |
| Decision Date | March 05, 1982 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAD — Retractor |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |