The following data is part of a premarket notification filed by Biopsy Sciences, Llc with the FDA for Bio-mark Resorbable Biopsy Site Marker And Bio-mark Permanent Biopsy Site Marker.
| Device ID | K023694 |
| 510k Number | K023694 |
| Device Name: | BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | BIOPSY SCIENCES, LLC 5582 CHALON RD. Yorba Linda, CA 92886 |
| Contact | Sharon Rockwell |
| Correspondent | Sharon Rockwell BIOPSY SCIENCES, LLC 5582 CHALON RD. Yorba Linda, CA 92886 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-01 |
| Decision Date | 2003-03-17 |
| Summary: | summary |