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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suction Control, Intracardiac, Cardiopulmonary Bypass
510(k) Number K895427
Device Name MEDISEAL SUCTION CANISTER
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact DEBRA F MANNING
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact DEBRA F MANNING
Regulation Number870.4430
Classification Product Code
DWD  
Date Received09/05/1989
Decision Date 01/19/1990
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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