The following data is part of a premarket notification filed by Innovative Surgical Products Inc. with the FDA for Disposable Irriga/aspir. System.
| Device ID | K821496 |
| 510k Number | K821496 |
| Device Name: | DISPOSABLE IRRIGA/ASPIR. SYSTEM |
| Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Applicant | INNOVATIVE SURGICAL PRODUCTS INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDH |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-19 |
| Decision Date | 1982-06-22 |