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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 K094018
FOIA Releasable 510(k) K094018
Device Name LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
Applicant
Biocompatibles UK Limited
20310 SW 48th St.
South West Ranches,  FL  33332
Applicant Contact JOHN GREENBAUM
Correspondent
Biocompatibles UK Limited
20310 SW 48th St.
South West Ranches,  FL  33332
Correspondent Contact JOHN GREENBAUM
Regulation Number882.5950
Classification Product Code
HCG  
Date Received12/29/2009
Decision Date 04/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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