510(k) K831081

EZEE FILTER/SEPARATOR by The Kendall Company Div. of Tyco Healthcare Group — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1983
Date Received
April 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type