The following data is part of a premarket notification filed by Biopsy Sciences, Llc with the FDA for Biopsy Sciences, Llc. Maxi-cell Biopsy Needles.
| Device ID | K021847 |
| 510k Number | K021847 |
| Device Name: | BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES |
| Classification | Biopsy Needle |
| 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 | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-05 |
| Decision Date | 2002-09-03 |
| Summary: | summary |