The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Durasafe B-d Combined Spinal Epidural Anesthesia.
Device ID | K932249 |
510k Number | K932249 |
Device Name: | DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA |
Classification | Anesthesia Conduction Kit |
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 | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-10 |
Decision Date | 1993-08-27 |