The following data is part of a premarket notification filed by Western Medical Products, Inc. with the FDA for Ophthalmic Knife & Forceps.
Device ID | K864266 |
510k Number | K864266 |
Device Name: | OPHTHALMIC KNIFE & FORCEPS |
Classification | Forceps, Ophthalmic |
Applicant | WESTERN MEDICAL PRODUCTS, INC. 15010 VENTURA BLVD. SUITE 220 Sherman Oaks, CA 91403 |
Contact | La Haba |
Correspondent | La Haba WESTERN MEDICAL PRODUCTS, INC. 15010 VENTURA BLVD. SUITE 220 Sherman Oaks, CA 91403 |
Product Code | HNR |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-29 |
Decision Date | 1986-11-28 |