The following data is part of a premarket notification filed by Baort, Inc. with the FDA for Surgical & Dental Instrument.
| Device ID | K854146 |
| 510k Number | K854146 |
| Device Name: | SURGICAL & DENTAL INSTRUMENT |
| Classification | Forceps, General & Plastic Surgery |
| Applicant | BAORT, INC. P.O. BOX 682 South Orange, NJ 07079 |
| Contact | Bayo Oshinnaiye |
| Correspondent | Bayo Oshinnaiye BAORT, INC. P.O. BOX 682 South Orange, NJ 07079 |
| Product Code | GEN |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-11 |
| Decision Date | 1985-11-13 |