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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Defoamer, Cardiopulmonary Bypass
510(k) Number K855049
Device Name MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
Applicant
Scimed Life Systems, Inc.
13000 County Rd. 6
Minneapolis,  MN  55441
Applicant Contact MICHAEL FRANKENBURG
Correspondent
Scimed Life Systems, Inc.
13000 County Rd. 6
Minneapolis,  MN  55441
Correspondent Contact MICHAEL FRANKENBURG
Regulation Number870.4230
Classification Product Code
DTP  
Date Received12/17/1985
Decision Date 02/26/1986
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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