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 |