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510(k) K081372

GELX ORAL GEL by Bmg Pharma, LLC — Product Code OLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2009
Date Received
May 16, 2008
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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