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510(k) K981299

SILVERLON CONTACT WOUND DRESSING by Argentum International, LLC — Product Code FRO

K981299 is an FDA 510(k) premarket notification submitted by Argentum International, LLC for the device "SILVERLON CONTACT WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on September 25, 1998. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Argentum International, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1998
Date Received
April 9, 1998
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 Argentum International, LLC

  • K984204 — SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP (March 19, 2007)
  • K984205 — SILVERLON ADHESIVE STRIP (March 19, 2007)
  • K984207 — SILVERLON DIRECT PRESSURE WOUND DRESSING (March 19, 2007)
  • K023612 — SILVERLON CONTACT WOUND DRESSING (January 24, 2003)
  • K023609 — SILVERLON ADHESIVE STRIP (January 17, 2003)
  • K984210 — SILVERLON WOUND PACKING STRIPS (September 24, 1999)
  • K984208 — SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD (February 22, 1999)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (September 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (August 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (August 11, 2026)
  • 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)

FDA data resources