The following data is part of a premarket notification filed by Biopsy Sciences, Llc with the FDA for Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker.
| Device ID | K083006 |
| 510k Number | K083006 |
| Device Name: | BIOPSY SCIENCES, INC., HYDROMARK BREAST 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-08 |
| Decision Date | 2009-02-09 |
| Summary: | summary |