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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 K063469
Device Name MEDICAN ALPHA
Applicant
EASTERN MEDIKIT LTD.
196, 205 PHASE-1 UDYOG VIHAR
GURAGON, HARYANA,  IN 122016
Applicant Contact RAJEEV ASRI
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact NEIL E DEVINE, JR.
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/16/2006
Decision Date 12/01/2006
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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