The following data is part of a premarket notification filed by Bioaccess, Inc. with the FDA for Bioaccess Marrow Harvest System.
| Device ID | K971114 |
| 510k Number | K971114 |
| Device Name: | BIOACCESS MARROW HARVEST SYSTEM |
| Classification | Needle, Aspiration And Injection, Reusable |
| 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 | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-26 |
| Decision Date | 1997-06-03 |
| Summary: | summary |