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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 K070020
Device Name COMCASET-P SAFETY IV CATHETER
Applicant
PITANGO MEDICAL LTD
3A JABOTINSKI ST, 28TH FLOOR
DIAMOND HOUSE-DORON LEVY
RAMAT GAN,  IL 52520
Applicant Contact BEN LEVIN
Correspondent
PITANGO MEDICAL LTD
3A JABOTINSKI ST, 28TH FLOOR
DIAMOND HOUSE-DORON LEVY
RAMAT GAN,  IL 52520
Correspondent Contact BEN LEVIN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received01/03/2007
Decision Date 08/16/2007
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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