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510(k) K140938

OSTOM-I ALERT by 11 Health and Technologies, LLC — Product Code EXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2014
Date Received
April 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Ostomy
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type

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