Home / 510(k) Clearances / K972385

510(k) K972385

FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED by Smiths Industries Medical Systems, Inc. — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1998
Date Received
June 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by Smiths Industries Medical Systems, Inc.

  • K965017 — REGIONAL ANESTHESIA TRAYS (March 14, 1997)
  • K962175 — PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE (January 17, 1997)
  • K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT (October 21, 1996)
  • K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (October 18, 1996)
  • K960429 — PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. IN (May 2, 1996)
  • K953485 — SIMS CPAP SYSTEM (October 26, 1995)
  • K953483 — SIMS BLUE LINE ENDOBRONCHIAL TUBE (October 24, 1995)
  • K932947 — WALLACE Y-CAN (September 1, 1995)
  • K932946 — WALLACE IV CANNULA (September 1, 1995)
  • K952516 — PRO-VENT, LINE DRAW, PULSATOR (July 14, 1995)

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