The following data is part of a premarket notification filed by Biopsy Sciences, Llc with the FDA for Biopsy Sciences Llc Hydromark Breast Biopsy Site Marker.
| Device ID | K130537 |
| 510k Number | K130537 |
| Device Name: | BIOPSY SCIENCES LLC 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 | 2013-03-01 |
| Decision Date | 2013-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911101571 | K130537 | 000 |
| 10841911102110 | K130537 | 000 |
| 10841911102165 | K130537 | 000 |
| 10841911102172 | K130537 | 000 |
| 10841911102257 | K130537 | 000 |
| 10841911100031 | K130537 | 000 |
| 10841911100062 | K130537 | 000 |
| 10841911100116 | K130537 | 000 |
| 10841911100123 | K130537 | 000 |
| 00841911100201 | K130537 | 000 |
| 10841911101410 | K130537 | 000 |
| 10841911101441 | K130537 | 000 |
| 10841911101489 | K130537 | 000 |
| 10841911101496 | K130537 | 000 |
| 10841911102080 | K130537 | 000 |