The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Multi-use I/a Handpiece.
| Device ID | K896305 |
| 510k Number | K896305 |
| Device Name: | MULTI-USE I/A HANDPIECE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | ADVANCED SURGICAL PRODUCTS, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Contact | James C Easley |
| Correspondent | James C Easley ADVANCED SURGICAL PRODUCTS, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-30 |
| Decision Date | 1989-12-18 |