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510(k) K792348

STANICOR, OMNI-STAN,MOD 333B,334A GAMMA by Cordis Corp. — Product Code DTX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1979
Date Received
November 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Control Unit, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4300
Review Panel
CV
Submission Type

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