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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K914316
Device Name CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH
Applicant
Medi-Flex Hospital Products, Inc.
8717 W. 110th St., Suite 750
Overland Park,  KS  66210
Applicant Contact ORLANDO CORDOVA
Correspondent
Medi-Flex Hospital Products, Inc.
8717 W. 110th St., Suite 750
Overland Park,  KS  66210
Correspondent Contact ORLANDO CORDOVA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received09/26/1991
Decision Date 12/24/1991
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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