The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Bard Parker Thoracic Vent.
Device ID | K854634 |
510k Number | K854634 |
Device Name: | BARD PARKER THORACIC VENT |
Classification | Bottle, Collection, Vacuum |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MACK CENTRE DR. P.O.BOX 2224 Paramus, NJ 07652 |
Contact | Russell Arnsberger |
Correspondent | Russell Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MACK CENTRE DR. P.O.BOX 2224 Paramus, NJ 07652 |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-19 |
Decision Date | 1985-12-27 |