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510(k) K970566

ARGLAES FILM DRESSING by Maersk Medical, Ltd. — Product Code FRO

Clearance Details

Decision
SN ()
Decision Date
July 29, 1997
Date Received
February 13, 1997
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)
  • K990810 — ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING (September 17, 1999)
  • K991759 — MAERSK MEDICAL CONTOUR INFUSION SET (June 25, 1999)

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