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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K952201
Device Name PORT-A-CATH ACCESS KIT
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 Number880.5860
Classification Product Code
FMF  
Date Received05/10/1995
Decision Date 10/04/1995
Decision Substantially Equivalent (SESE)
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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