The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Ruby Knives For Ophth. Surgery.
Device ID | K832844 |
510k Number | K832844 |
Device Name: | RUBY KNIVES FOR OPHTH. SURGERY |
Classification | Knife, Ophthalmic |
Applicant | KEELER INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HNN |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-22 |
Decision Date | 1983-09-29 |