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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 K033761
Device Name GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
Applicant
BIOCOMPATIBLES U.K. LIMITED
20310 SW 48TH STREET
FT. LAUDERDALE,  FL  33332
Applicant Contact JOHN GREENBAUM
Correspondent
BIOCOMPATIBLES U.K. LIMITED
20310 SW 48TH STREET
FT. LAUDERDALE,  FL  33332
Correspondent Contact JOHN GREENBAUM
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received12/02/2003
Decision Date 02/04/2004
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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