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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 K042231
FOIA Releasable 510(k) K042231
Device Name GELSPHERES MICROSPHERES AND BEAD BLOCK 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  
Date Received08/17/2004
Decision Date 11/12/2004
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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