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510(k) K990810

ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING by Maersk Medical, Ltd. — Product Code FRO

K990810 is an FDA 510(k) premarket notification submitted by Maersk Medical, Ltd. for the device "ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING". The FDA issued a decision of Substantially Equivalent on September 17, 1999. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Maersk Medical, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1999
Date Received
March 11, 1999
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 Maersk Medical, Ltd.

  • K011071 — PARADIGM QUICK-SET INFUSION SET (June 7, 2001)
  • K004028 — ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING (March 27, 2001)
  • K002138 — PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 (August 29, 2000)
  • K990111 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 (December 6, 1999)
  • K990115 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 (December 6, 1999)
  • K990113 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 45 (December 6, 1999)
  • K990112 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 (December 6, 1999)
  • K990110 — DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 (December 6, 1999)
  • K991759 — MAERSK MEDICAL CONTOUR INFUSION SET (June 25, 1999)
  • K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (March 17, 1998)

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