The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Advanced Surgical Products Scleral Plug Forceps.
Device ID | K880274 |
510k Number | K880274 |
Device Name: | ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS |
Classification | Forceps, 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 | HNR |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-21 |
Decision Date | 1988-02-05 |