The following data is part of a premarket notification filed by Bioaccess, Inc. with the FDA for Bioaccess Bone Biopsy System.
| Device ID | K954151 |
| 510k Number | K954151 |
| Device Name: | BIOACCESS BONE BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | BIOACCESS, INC. 8400 CEDAR ST. Silver Spring, MD 20910 |
| Contact | Peter J Carnes |
| Correspondent | Peter J Carnes BIOACCESS, INC. 8400 CEDAR ST. Silver Spring, MD 20910 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1995-09-15 |