The following data is part of a premarket notification filed by Innovative Surgical Products Inc. with the FDA for Acuvac(tm) Suction Reservoir 400cc And.
| Device ID | K801350 |
| 510k Number | K801350 |
| Device Name: | ACUVAC(TM) SUCTION RESERVOIR 400CC AND |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | INNOVATIVE SURGICAL PRODUCTS INC. CA |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-09 |
| Decision Date | 1980-07-14 |