The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Bd Perisafe Epidural Anesthesia Tray.
Device ID | K953790 |
510k Number | K953790 |
Device Name: | BD PERISAFE EPIDURAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
Contact | Gregory W Morgan |
Correspondent | Gregory W Morgan BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE 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 | 1995-08-14 |
Decision Date | 1995-11-30 |
Summary: | summary |