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510(k) K172720

TRACOE silcosoft Tracheostomy Tube by Tracoe Medical GmbH — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2018
Date Received
September 8, 2017
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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  • 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)
  • K961449 — TRACHEOSTOMY TUBES TRACOE-FLEX (September 13, 1996)
  • K781729 — TRACHEOTOMY TUBES (October 24, 1978)

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