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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K860523
Device Name CARDIO-COOL
Applicant
Bio-Vascular, Inc.
2670 Patton Rd.
St. Paul,  MN  55113
Applicant Contact ANN M RILEY
Correspondent
Bio-Vascular, Inc.
2670 Patton Rd.
St. Paul,  MN  55113
Correspondent Contact ANN M RILEY
Regulation Number870.4240
Classification Product Code
DTR  
Date Received02/12/1986
Decision Date 04/29/1986
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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