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510(k) K832363

FOLEY CATHETERIZATION TRAY-VARIOUS by Inmed Corp. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1984
Date Received
July 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Inmed Corp.

  • K862672 — ESOPHAGEAL STETHOSCOPE WITH THERMISTOR (October 27, 1986)
  • K853162 — STERILE NASOPHARYNGEAL AIRWAY (August 6, 1985)
  • K850248 — DISPOSABLE GUEDEL AIRWAY (March 12, 1985)
  • K850152 — PRECONNECTED URETHRAL CATHETER TRAY (March 12, 1985)
  • K850335 — URETEROSCOPY CATHETER (March 12, 1985)
  • K844801 — ULTRA EXTERNAL CATHETER (January 15, 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)

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