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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 K023089
Device Name GELSPHERES EMBOLIC AGENT
Applicant
BIOCURE, INC.
20310 SW 48TH ST.
FT. LAUDERDALE,  FL  33332 -1111
Applicant Contact JOHN GREENBAUM
Correspondent
BIOCURE, INC.
20310 SW 48TH ST.
FT. LAUDERDALE,  FL  33332 -1111
Correspondent Contact JOHN GREENBAUM
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received09/17/2002
Decision Date 12/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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