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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 K832811
Device Name SHILEY 3L CARDF PLUS
Applicant
Shiley, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Shiley, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.4230
Classification Product Code
DTP  
Date Received08/18/1983
Decision Date 09/20/1983
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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