The following data is part of a premarket notification filed by Biopsy Sciences, Llc with the FDA for Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker.
| Device ID | K121113 |
| 510k Number | K121113 |
| Device Name: | BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER |
| Classification | Marker, Radiographic, Implantable |
| Applicant | BIOPSY SCIENCES, LLC 5582 CHALON RD. Yorba Linda, FL 33760 |
| Contact | Sharon Rockwell |
| Correspondent | Sharon Rockwell BIOPSY SCIENCES, LLC 5582 CHALON RD. Yorba Linda, FL 33760 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-12 |
| Decision Date | 2012-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911102059 | K121113 | 000 |
| 10841911102233 | K121113 | 000 |
| 10841911102240 | K121113 | 000 |
| 10841911100000 | K121113 | 000 |
| 10841911100017 | K121113 | 000 |
| 10841911100024 | K121113 | 000 |
| 10841911100048 | K121113 | 000 |
| 10841911100055 | K121113 | 000 |
| 10841911100079 | K121113 | 000 |
| 10841911102226 | K121113 | 000 |
| 10841911102219 | K121113 | 000 |
| 10841911102202 | K121113 | 000 |
| 10841911102066 | K121113 | 000 |
| 20841911100021 | K121113 | 000 |
| 10841911102097 | K121113 | 000 |
| 10841911102103 | K121113 | 000 |
| 10841911102127 | K121113 | 000 |
| 10841911102134 | K121113 | 000 |
| 10841911102141 | K121113 | 000 |
| 10841911102158 | K121113 | 000 |
| 10841911100086 | K121113 | 000 |
| 10841911100093 | K121113 | 000 |
| 10841911101458 | K121113 | 000 |
| 10841911101465 | K121113 | 000 |
| 10841911101472 | K121113 | 000 |
| 10841911101526 | K121113 | 000 |
| 10841911101533 | K121113 | 000 |
| 10841911101540 | K121113 | 000 |
| 10841911101557 | K121113 | 000 |
| 10841911101564 | K121113 | 000 |
| 10841911101434 | K121113 | 000 |
| 10841911101427 | K121113 | 000 |
| 10841911101403 | K121113 | 000 |
| 10841911100109 | K121113 | 000 |
| 10841911100154 | K121113 | 000 |
| 10841911100161 | K121113 | 000 |
| 10841911100178 | K121113 | 000 |
| 10841911100185 | K121113 | 000 |
| 10841911100192 | K121113 | 000 |
| 10841911101380 | K121113 | 000 |
| 10841911101397 | K121113 | 000 |
| 10841911101694 | K121113 | 000 |