The following data is part of a premarket notification filed by Surg-assist, Inc. with the FDA for Surg/assist Model Sa-1.
| Device ID | K912422 |
| 510k Number | K912422 |
| Device Name: | SURG/ASSIST MODEL SA-1 |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | SURG-ASSIST, INC. 10691 CHAMPAGNE RD. Alta Loma, CA 91701 |
| Contact | Andrew P Frisque |
| Correspondent | Andrew P Frisque SURG-ASSIST, INC. 10691 CHAMPAGNE RD. Alta Loma, CA 91701 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-31 |
| Decision Date | 1991-08-12 |