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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 K052564
Device Name VYGON LEADER-FLEX
Applicant
VYGON CORP.
2495 GENERAL ARMISTEAD AVE
NORRISTOWN,  PA  19403
Applicant Contact COURTNEY SMITH
Correspondent
VYGON CORP.
2495 GENERAL ARMISTEAD AVE
NORRISTOWN,  PA  19403
Correspondent Contact COURTNEY SMITH
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/19/2005
Decision Date 04/05/2006
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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