The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Precision Harvest & Inlay Instrument Set.
| Device ID | K851339 |
| 510k Number | K851339 |
| Device Name: | PRECISION HARVEST & INLAY INSTRUMENT SET |
| Classification | Trephine |
| Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Contact | Penny C Rasmussen |
| Correspondent | Penny C Rasmussen CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Product Code | HWK |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-03 |
| Decision Date | 1985-07-02 |