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510(k) K221218

Silverlon Wound Contact, Burn Contact Dressings by Argentum Medical, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2022
Date Received
April 27, 2022
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, Inc.

  • K241225 — Silverlon® Wound Contact, Burn Contact Dressing (July 31, 2024)
  • 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)
  • K053590 — SILVERLON CA (CALCIUM ALGINATE) (October 6, 2006)

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