510(k) K841117

GASPAK PLUS DISPOS. HYDROGEN & by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
March 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Gas Generating
Device Class
Class I
Regulation Number
866.2580
Review Panel
MI
Submission Type