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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 K801375
Device Name SHILEY CARDIOTOMY RESERVOIR W/FILTER
Applicant
SHILEY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SHILEY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.4230
Classification Product Code
DTP  
Date Received06/11/1980
Decision Date 07/14/1980
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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