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510(k) K840973

COLE TUBE-LATEX by Inmed Corp. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1984
Date Received
March 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Inmed Corp.

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