510(k) K955038

STOCKERT S3 DOUBLE HEAD PUMP MODULE by Stoeckert Instrumente — Product Code DWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1996
Date Received
November 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class
Class II
Regulation Number
870.4370
Review Panel
CV
Submission Type