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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K832058
Device Name ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV.
Applicant
PARKE-DAVIS CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PARKE-DAVIS CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1210
Classification Product Code
KRA  
Date Received06/27/1983
Decision Date 09/12/1983
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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