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FDA 510(k) Application Details - K081768
Device Classification Name
Agents,Embolic,For Treatment Of Uterine Fibroids
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510(K) Number
K081768
Device Name
Agents,Embolic,For Treatment Of Uterine Fibroids
Applicant
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 US
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Contact
SUSANNE GALIN
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Regulation Number
870.3300
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Classification Product Code
NAJ
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More FDA Info for this Product Code
Date Received
06/20/2008
Decision Date
12/23/2008
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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