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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, neurovascular embolization
510(k) Number K913556
Device Name IVALON EMBOLIZATION PARTICLES
Applicant
IVALON
5374 LINDA VISTA RD., SUITE C
SAN DIEGO,  CA  92110
Applicant Contact ELIZABETH MELARAGNO
Correspondent
IVALON
5374 LINDA VISTA RD., SUITE C
SAN DIEGO,  CA  92110
Correspondent Contact ELIZABETH MELARAGNO
Regulation Number882.5950
Classification Product Code
HCG  
Date Received08/09/1991
Decision Date 04/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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