The following data is part of a premarket notification filed by Advanced Surgical Products, Inc. with the FDA for Mvr/stiletto Blade 20ga. - P/n 1900.
Device ID | K881669 |
510k Number | K881669 |
Device Name: | MVR/STILETTO BLADE 20GA. - P/N 1900 |
Classification | Knife, 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 | HNN |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-18 |
Decision Date | 1988-05-13 |