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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 K820954
Device Name SCIMED MODEL SC 3000
Applicant
SCIMED LIFE SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SCIMED LIFE SYSTEMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.4230
Classification Product Code
DTP  
Date Received04/06/1982
Decision Date 05/24/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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