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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 Rd.
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
Predetermined Change
Control Plan Authorized		 No
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