510(k) K113836

BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) by Avery Dennison Belgie Bvba — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2012
Date Received
December 28, 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