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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory Equipment, Cardiopulmonary Bypass
510(k) Number K781861
Device Name FILTER, EXTRACORPOREAL BLOOD HOLDER
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 Number870.4200
Classification Product Code
KRI  
Date Received11/06/1978
Decision Date 11/15/1978
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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