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FDA 510(k) Application Details - K030966
Device Classification Name
Agents,Embolic,For Treatment Of Uterine Fibroids
More FDA Info for this Device
510(K) Number
K030966
Device Name
Agents,Embolic,For Treatment Of Uterine Fibroids
Applicant
BOSTON SCIENTIFIC CORP.
10 GLENS FALLS TECHNICAL PARK
GLENS FALLS, NY 12801-3864 US
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Contact
JODI LYNN GREENIZEN
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Regulation Number
870.3300
More FDA Info for this Regulation Number
Classification Product Code
NAJ
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More FDA Info for this Product Code
Date Received
03/27/2003
Decision Date
09/23/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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