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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 K791844
Device Name CRITIFLO & CRITIFLO DOME
Applicant
GOULD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Applicant Contact None None
Correspondent
GOULD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent Contact None None
Regulation Number870.1210
Classification Product Code
KRA  
Date Received09/19/1979
Decision Date 10/02/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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