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510(k) K081768

COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES by Cook Incorporated — Product Code NAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2008
Date Received
June 20, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class
Class II
Regulation Number
870.3300
Review Panel
OB
Submission Type

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