The following data is part of a premarket notification filed by Sanarus Medical, Inc. with the FDA for Modification To Sanarus Centrica Core Tissue Biopsy.
| Device ID | K022879 |
| 510k Number | K022879 |
| Device Name: | MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY |
| Classification | Instrument, Biopsy |
| Applicant | SANARUS MEDICAL, INC. 5880 WEST LAS POSITAS,SUITE 52 Pleasanton, CA 94588 |
| Contact | Vincent Cutarelli |
| Correspondent | Vincent 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-30 |
| Decision Date | 2002-09-23 |
| Summary: | summary |