The following data is part of a premarket notification filed by Innovative Surgical Products Inc. with the FDA for Disposable Vitrectomy Handpiece.
| Device ID | K832235 |
| 510k Number | K832235 |
| Device Name: | DISPOSABLE VITRECTOMY HANDPIECE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | INNOVATIVE SURGICAL PRODUCTS INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-11 |
| Decision Date | 1983-09-29 |