The following data is part of a premarket notification filed by Innovative Surgical Products Inc. with the FDA for Ispvac Tm.
| Device ID | K802973 |
| 510k Number | K802973 |
| Device Name: | ISPVAC TM |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | INNOVATIVE SURGICAL PRODUCTS INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-18 |
| Decision Date | 1980-12-19 |