The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Prisma Disposable Endo-ocular Probe.
Device ID | K875000 |
510k Number | K875000 |
Device Name: | PRISMA DISPOSABLE ENDO-OCULAR PROBE |
Classification | Laser, Ophthalmic |
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 | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-04 |
Decision Date | 1988-04-13 |