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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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