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510(k) K844801

ULTRA EXTERNAL CATHETER by Inmed Corp. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1985
Date Received
December 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Inmed Corp.

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  • K850248 — DISPOSABLE GUEDEL AIRWAY (March 12, 1985)
  • K850152 — PRECONNECTED URETHRAL CATHETER TRAY (March 12, 1985)
  • K850335 — URETEROSCOPY CATHETER (March 12, 1985)
  • K842301 — DISPOSABLE LATEX BANDAGE (November 5, 1984)
  • K842866 — URETHRAL CATHETERIZATION TRAY (September 10, 1984)
  • K841040 — FOX POST NASAL BALLOON CATHETER (August 17, 1984)
  • K842865 — ESOPHAGEAL STETHOSCOPE (August 15, 1984)
  • K841037 — PENROSE DRAINS (April 25, 1984)

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