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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 K141026
Device Name LEADERFLEX
Applicant
VYGON
2750 MORRIS ROAD, SUITE A200
LANSDALE,  PA  19446
Applicant Contact JILLIAN MIKOVICH
Correspondent
VYGON
2750 MORRIS ROAD, SUITE A200
LANSDALE,  PA  19446
Correspondent Contact JILLIAN MIKOVICH
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/22/2014
Decision Date 07/30/2014
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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