The following data is part of a premarket notification filed by Alpha Surgical, Inc. with the FDA for Airframe Surgical Drape Support.
| Device ID | K942699 |
| 510k Number | K942699 |
| Device Name: | AIRFRAME SURGICAL DRAPE SUPPORT |
| Classification | Table And Attachments, Operating-room |
| Applicant | ALPHA SURGICAL, INC. 2116 ANDREW DR. Eau Claire, WI 54701 |
| Contact | Timothy J Juntunen |
| Correspondent | Timothy J Juntunen ALPHA SURGICAL, INC. 2116 ANDREW DR. Eau Claire, WI 54701 |
| Product Code | BWN |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-08 |
| Decision Date | 1994-07-13 |