The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Loss Of Resistance Syringe.
Device ID | K925902 |
510k Number | K925902 |
Device Name: | B-D LOSS OF RESISTANCE SYRINGE |
Classification | Anesthesia Conduction Kit |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | J Arnsberger |
Correspondent | J Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-20 |
Decision Date | 1993-01-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382904052923 | K925902 | 000 |
50382904052916 | K925902 | 000 |