Home / 510(k) Clearances / K990810

510(k) K990810

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

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)
  • K990112 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 (December 6, 1999)
  • K990111 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 (December 6, 1999)
  • K990110 — DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 (December 6, 1999)
  • K990113 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 45 (December 6, 1999)
  • K990115 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 (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)

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