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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Prebypass, Cardiopulmonary Bypass
510(k) Number K861226
Device Name INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70
Applicant
Medical, Inc.
9605 W. Jefferson Trl.
Inver Grove Heights,  MN  55077
Applicant Contact MIKHAIL, PHD
Correspondent
Medical, Inc.
9605 W. Jefferson Trl.
Inver Grove Heights,  MN  55077
Correspondent Contact MIKHAIL, PHD
Regulation Number870.4280
Classification Product Code
KRJ  
Date Received04/01/1986
Decision Date 06/02/1986
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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