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510(k) K101769

EPISIL by Camurus AB — Product Code OLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2011
Date Received
June 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oral Wound Dressing
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per SE to MGQ.

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