The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Prisma Tech 19 Gauge Disposable Extrusion Needles.
| Device ID | K881927 |
| 510k Number | K881927 |
| Device Name: | PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | ADVANCED SURGICAL PRODUCTS, INC. 744 GODDARD Chesterfield, MO 63017 |
| Contact | Todd J Hessel |
| Correspondent | Todd J Hessel ADVANCED SURGICAL PRODUCTS, INC. 744 GODDARD Chesterfield, MO 63017 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-09 |
| Decision Date | 1988-05-25 |