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510(k) K110762

AVO BARRIER TOPICAL EMULSION by Trigen Laboratories, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2011
Date Received
March 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Trigen Laboratories, Inc.

  • K121134 — TL TRISEB CREAM (July 25, 2012)
  • K110757 — TL-CERMIDE SKIN BARRIER EMULSION (August 19, 2011)

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