The following data is part of a premarket notification filed by Sanarus Medical, Inc. with the FDA for Sanarus Incore Rotational Core Biopsy Device, Models Cb3010, Cb3012.
| Device ID | K080171 |
| 510k Number | K080171 |
| Device Name: | SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012 |
| Classification | Instrument, Biopsy |
| Applicant | SANARUS MEDICAL, INC. 4696 WILLOW RD. Pleasanton, CA 94588 |
| Contact | Lisa Henry |
| Correspondent | Lisa Henry SANARUS MEDICAL, INC. 4696 WILLOW RD. Pleasanton, CA 94588 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-24 |
| Decision Date | 2008-03-06 |
| Summary: | summary |