The following data is part of a premarket notification filed by Sanarus Medical, Inc. with the FDA for Sanarus Centrica Core Tissue Biopsy System.
| Device ID | K021137 |
| 510k Number | K021137 |
| Device Name: | SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | SANARUS MEDICAL, INC. 5880 WEST LAS POSITAS,SUITE 52 Pleasanton, CA 94588 |
| Contact | Vicent Cutarelli |
| Correspondent | Vicent Cutarelli 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-09 |
| Decision Date | 2002-06-26 |
| Summary: | summary |