The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Soft Tissue Biopsy Needle.
Device ID | K870785 |
510k Number | K870785 |
Device Name: | SOFT TISSUE BIOPSY NEEDLE |
Classification | Instrument, Biopsy |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | R. J Arnsberger |
Correspondent | R. J Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-26 |
Decision Date | 1987-04-01 |