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510(k) K122932

SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT by Fogless International AB — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2013
Date Received
September 24, 2012
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

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