The following data is part of a premarket notification filed by Sanarus Medical, Inc. with the FDA for Sanarus Cassi Rotational Core Biopsy System.
| Device ID | K042136 |
| 510k Number | K042136 |
| Device Name: | SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | SANARUS MEDICAL, INC. 5880 WEST LAS POSITAS,SUITE 52 Pleasanton, CA 94588 |
| Contact | Trena Depel |
| Correspondent | Trena Depel SANARUS MEDICAL, INC. 5880 WEST LAS POSITAS,SUITE 52 Pleasanton, CA 94588 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-09-08 |
| Summary: | summary |