The following data is part of a premarket notification filed by Biopsys Medical, Inc. with the FDA for Retractor Arm Clamp.
| Device ID | K960019 |
| 510k Number | K960019 |
| Device Name: | RETRACTOR ARM CLAMP |
| Classification | Operating Room Accessories Table Tray |
| Applicant | BIOPSYS MEDICAL, INC. 3 MORGAN Irvine, CA 92618 |
| Contact | Mark A Cole |
| Correspondent | Mark A Cole BIOPSYS MEDICAL, INC. 3 MORGAN Irvine, CA 92618 |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-02-09 |