The following data is part of a premarket notification filed by Biopsys Medical, Inc. with the FDA for Mammotome Biopsy Probe And Housing (mammotome).
| Device ID | K970565 |
| 510k Number | K970565 |
| Device Name: | MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) |
| Classification | Instrument, Biopsy |
| Applicant | BIOPSYS MEDICAL, INC. 3 MORGAN Irvine, CA 92618 |
| Contact | Mark A Cole, Ph.d. |
| Correspondent | Mark A Cole, Ph.d. BIOPSYS MEDICAL, INC. 3 MORGAN Irvine, CA 92618 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-13 |
| Decision Date | 1997-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841911100539 | K970565 | 000 |