The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Ultra Fine(r) Lancet.
Device ID | K932725 |
510k Number | K932725 |
Device Name: | B-D ULTRA FINE(R) LANCET |
Classification | Lancet, Blood |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | Russell Arnsberger |
Correspondent | Russell Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Product Code | FMK |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-07 |
Decision Date | 1993-07-23 |