510(k) K791130

FLU-VEN TK-2 by Venospital, Inc. — Product Code KSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1979
Date Received
June 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Transfer (Blood/Plasma)
Device Class
Class II
Regulation Number
864.9875
Review Panel
HE
Submission Type