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510(k) K103141

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

K103141 is an FDA 510(k) premarket notification submitted by Milliken Healthcare Products, LLC for the device "LOW ADHERENT AFM AG DRESSINGS". The FDA issued a decision of Substantially Equivalent on January 21, 2011. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Milliken Healthcare Products, LLC has at least 2 other 510(k) clearances on record.

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

Other clearances by Milliken Healthcare Products, LLC

  • K141603 — Ultra Silver Dressings (October 22, 2014)
  • K110715 — INTERDRY SILVER (November 4, 2011)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources