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510(k) K053590

SILVERLON CA (CALCIUM ALGINATE) by Argentum Medical, LLC — Product Code FRO

K053590 is an FDA 510(k) premarket notification submitted by Argentum Medical, LLC for the device "SILVERLON CA (CALCIUM ALGINATE)". The FDA issued a decision of Substantially Equivalent on October 6, 2006. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Argentum Medical, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2006
Date Received
December 23, 2005
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 Medical, LLC

  • K241225 — Silverlon® Wound Contact, Burn Contact Dressing (July 31, 2024)
  • K221218 — Silverlon Wound Contact, Burn Contact Dressings (October 26, 2022)
  • K190343 — Silverlon Wound Contact, Burn Contact Dressings (July 18, 2019)
  • K180570 — Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Sil (January 14, 2019)
  • K150256 — SILVERLON BURN CONTACT DRESSINGS (April 30, 2015)
  • K143001 — SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING (November 7, 2014)
  • K141033 — SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EAS (September 12, 2014)
  • K141573 — SILVERLON ISLAND WOUND DRESSING (August 28, 2014)
  • K122817 — SILVERLON ISLAND WOUND DRESSING (May 1, 2014)

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