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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Apparatus, Suction, Patient Care
510(k) Number K803037
Device Name WILLIAM HARVEY VENTED MEDIASTINAL DRAIN
Applicant
C.R. BARD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
C.R. BARD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.5050
Classification Product Code
DWM  
Date Received12/01/1980
Decision Date 02/04/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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