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510(k) K052229

COLOPLAST OSTOMY ROD, MODEL 12814 by Coloplast Corp. — Product Code EZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2006
Date Received
August 16, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Colostomy
Device Class
Class II
Regulation Number
876.4270
Review Panel
GU
Submission Type

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