The following data is part of a premarket notification filed by Biopsys Medical, Inc. with the FDA for Surgical Staple Marker Device (modify).
| Device ID | K963015 |
| 510k Number | K963015 |
| Device Name: | SURGICAL STAPLE MARKER DEVICE (MODIFY) |
| Classification | Staple, Implantable |
| 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 | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-25 |
| Decision Date | 1996-10-07 |
| Summary: | summary |