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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K952256
Device Name PICC LINE KIT
Applicant
Medi-Flex Hospital Products, Inc.
19 Butterfield Trl.
El Paso,  TX  79906
Applicant Contact ORLANDO CORDOVA
Correspondent
Medi-Flex Hospital Products, Inc.
19 Butterfield Trl.
El Paso,  TX  79906
Correspondent Contact ORLANDO CORDOVA
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/15/1995
Decision Date 07/31/1995
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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