The following data is part of a premarket notification filed by Precision Instruments, Inc. with the FDA for Hessburg-bfrron Trephine.
| Device ID | K801585 |
| 510k Number | K801585 |
| Device Name: | HESSBURG-BFRRON TREPHINE |
| Classification | Knife, Surgical |
| Applicant | PRECISION INSTRUMENTS, INC. MI |
| Product Code | EMF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-11 |
| Decision Date | 1980-10-03 |