The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Rk-m & Rk-dk Diamond Knives With Measuring Gauge.
| Device ID | K864290 |
| 510k Number | K864290 |
| Device Name: | RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE |
| Classification | Knife, Ophthalmic |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Van Arsdale |
| Correspondent | Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HNN |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-31 |
| Decision Date | 1986-12-15 |