K870781 is an FDA 510(k) clearance for the ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS. This device is classified as a Elevator, Surgical, General & Plastic Surgery (Class I - General Controls, product code GEG).
Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on March 9, 1987, 11 days after receiving the submission on February 26, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K870781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1987 |
| Decision Date | March 09, 1987 |
| Days to Decision | 11 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 |