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FDA 510(k) Applications Submitted by BIOSPHERE MEDICAL, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K062126
07/26/2006
EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
BIOSPHERE MEDICAL, INC.
K010026
01/03/2001
EMBOGOLD MICROSPHERE
BIOSPHERE MEDICAL, INC.
K113822
12/27/2011
QUADRASPHERE 30 TO 60
BIOSPHERE MEDICAL, INC.
K061171
04/27/2006
SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
BIOSPHERE MEDICAL, INC.
K052742
09/30/2005
HEPASPHERE MICROSPHERES
BIOSPHERE MEDICAL, INC.
K021397
05/02/2002
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
BIOSPHERE MEDICAL, INC.
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