The following data is part of a premarket notification filed by Biopsy Sciences, Llc with the FDA for Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-t1, 4005-02-15-s1, 4005-03-15-t1, 4005-03-15-s1.
| Device ID | K090501 |
| 510k Number | K090501 |
| Device Name: | BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 |
| 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 | 2009-02-25 |
| Decision Date | 2009-03-05 |
| Summary: | summary |