The following data is part of a premarket notification filed by Artemis Medical, Inc. with the FDA for Caris Site Marker.
| Device ID | K003777 |
| 510k Number | K003777 |
| Device Name: | CARIS SITE MARKER |
| Classification | Clip, Implantable |
| Applicant | ARTEMIS MEDICAL, INC. 655 MARINERS ISLAND BLVD. SUITE 303 San Mateo, CA 94404 |
| Contact | Robin Bush |
| Correspondent | Robin Bush ARTEMIS MEDICAL, INC. 655 MARINERS ISLAND BLVD. SUITE 303 San Mateo, CA 94404 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-07 |
| Decision Date | 2001-03-06 |