The following data is part of a premarket notification filed by Precision Instruments, Inc. with the FDA for Ring Supported Trephine For Cornea Trans.
| Device ID | K843048 |
| 510k Number | K843048 |
| Device Name: | RING SUPPORTED TREPHINE FOR CORNEA TRANS |
| Classification | Trephine, Manual, Ophthalmic |
| Applicant | PRECISION INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HRH |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-03 |
| Decision Date | 1984-10-05 |