The following data is part of a premarket notification filed by Sanarus Medical, Inc. with the FDA for Sanarus Indica Marker System.
| Device ID | K020054 |
| 510k Number | K020054 |
| Device Name: | SANARUS INDICA MARKER SYSTEM |
| Classification | Clip, Implantable |
| 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 | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-08 |
| Decision Date | 2002-10-16 |
| Summary: | summary |