The following data is part of a premarket notification filed by Innovative Surgical Products Inc. with the FDA for Heslin Dispos. Tubing Set.
| Device ID | K843041 |
| 510k Number | K843041 |
| Device Name: | HESLIN DISPOS. TUBING SET |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | INNOVATIVE SURGICAL PRODUCTS INC. 1201 EAST WAKEHAM Santa Ana, CA 92705 |
| Contact | Duane Mason |
| Correspondent | Duane Mason INNOVATIVE SURGICAL PRODUCTS INC. 1201 EAST WAKEHAM Santa Ana, CA 92705 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-02 |
| Decision Date | 1984-11-21 |