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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 K062108
Device Name COMCASET 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
KEMA QUALITY B.V.
4377 COUNTY LINE ROAD
CHALFONT,  PA  18914
Correspondent Contact PATRICIA L MURPHY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/24/2006
Decision Date 08/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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