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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K790804
Device Name PURGE LINE UNIT
Applicant
SURGIKOS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SURGIKOS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.4290
Classification Product Code
DTL  
Date Received04/24/1979
Decision Date 05/25/1979
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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