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510(k) K963756

IBC CARDIAC SUCTION WARD by International Biophysics Corp. — Product Code DTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1997
Date Received
September 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4420
Review Panel
CV
Submission Type

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