The following data is part of a premarket notification filed by Precision Instruments, Inc. with the FDA for Barron Twin Blade Trephine For Eppikaratophakia.
| Device ID | K860648 |
| 510k Number | K860648 |
| Device Name: | BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA |
| Classification | Trephine, Manual, Ophthalmic |
| Applicant | PRECISION INSTRUMENTS, INC. 6437 CARRIAGE HILL DR. Grand Blanc, MI 48439 |
| Contact | Milford Barron |
| Correspondent | Milford Barron PRECISION INSTRUMENTS, INC. 6437 CARRIAGE HILL DR. Grand Blanc, MI 48439 |
| Product Code | HRH |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-20 |
| Decision Date | 1986-03-25 |