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 |