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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K930196
Device Name CEPTI-SEAL I.V. PREP 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 Number880.5200
Classification Product Code
LRS  
Date Received01/14/1993
Decision Date 07/02/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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