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510(k) K961449

TRACHEOSTOMY TUBES TRACOE-FLEX by Tracoe Medical GmbH — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1996
Date Received
April 16, 1996
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 Tracoe Medical GmbH

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  • K172720 — TRACOE silcosoft Tracheostomy Tube (April 27, 2018)
  • K152778 — TRACOE Cuff Pressure Monitor (December 21, 2016)
  • K152865 — TRACOE smart Cuff Manager (September 27, 2016)
  • K051587 — TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, (October 25, 2005)
  • K043160 — TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO (February 18, 2005)
  • K781729 — TRACHEOTOMY TUBES (October 24, 1978)

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  • K180034 — Weinmann Tracheostomy Exchange Set (May 7, 2018)
  • K172720 — TRACOE silcosoft Tracheostomy Tube (April 27, 2018)
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