The following data is part of a premarket notification filed by Artemis Medical, Inc. with the FDA for 14g Cormark Biopsy Site Identifier.
| Device ID | K032217 |
| 510k Number | K032217 |
| Device Name: | 14G CORMARK BIOPSY SITE IDENTIFIER |
| Classification | Clip, Implantable |
| Applicant | ARTEMIS MEDICAL, INC. 21021 CORSAIR BLVD. Hayward, CA 94545 |
| Contact | Linda Guthrie |
| Correspondent | Linda Guthrie ARTEMIS MEDICAL, INC. 21021 CORSAIR BLVD. Hayward, CA 94545 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2003-08-21 |
| Summary: | summary |