510(k) K103141

LOW ADHERENT AFM AG DRESSINGS by Milliken Healthcare Products, LLC — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2011
Date Received
October 25, 2010
Clearance Type
Special
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