K942699 is an FDA 510(k) clearance for the AIRFRAME SURGICAL DRAPE SUPPORT. This device is classified as a Table And Attachments, Operating-room (Class I - General Controls, product code BWN).
Submitted by Alpha Surgical, Inc. (Eau Claire, US). The FDA issued a Cleared decision on July 13, 1994, 35 days after receiving the submission on June 8, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K942699 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1994 |
| Decision Date | July 13, 1994 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | BWN — Table And Attachments, Operating-room |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |