The following data is part of a premarket notification filed by Biopsys Medical, Inc. with the FDA for Biopsy Device Accessory.
| Device ID | K944252 |
| 510k Number | K944252 |
| Device Name: | BIOPSY DEVICE ACCESSORY |
| Classification | Instrument, Biopsy, Suction |
| Applicant | BIOPSYS MEDICAL, INC. 27130 A PASEO ESPADA, SUITE 1424 San Juan Capistrano, CA 92675 |
| Contact | Mark A Cole |
| Correspondent | Mark A Cole BIOPSYS MEDICAL, INC. 27130 A PASEO ESPADA, SUITE 1424 San Juan Capistrano, CA 92675 |
| Product Code | FCK |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-30 |
| Decision Date | 1994-12-05 |