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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 K111939
Device Name M/29TM - PRESSURE INJECTABLE
Applicant
FLEXICATH LTD.
120 YIGAL ALON ST.
CALIFORNIA BLDG, SUITE 107
TEL AVIV,  IL 67443
Applicant Contact TALI HAZAN
Correspondent
FLEXICATH LTD.
120 YIGAL ALON ST.
CALIFORNIA BLDG, SUITE 107
TEL AVIV,  IL 67443
Correspondent Contact TALI HAZAN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/08/2011
Decision Date 07/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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