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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Roller Type
510(k) Number K813035
Device Name POLYSTAN VERTICLUDE BLOOD PUMP
Applicant
ADVOCACY INTERNATIONAL, LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ADVOCACY INTERNATIONAL, LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.4370
Classification Product Code
DWB  
Date Received10/28/1981
Decision Date 11/27/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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