The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Dynacyt Biopsy Aspiration Device.
| Device ID | K922919 |
| 510k Number | K922919 |
| Device Name: | DYNACYT BIOPSY ASPIRATION DEVICE |
| Classification | Device, Percutaneous, Biopsy |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | MJG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-17 |
| Decision Date | 1993-03-31 |