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FDA 510(k), K122932, SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
FDA 510(k), K122932, SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
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510(K) Number: K122932
Device Name: SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
Manufacturer: JASON WALTON
Device Classification Name: Tube Tracheostomy And Tube Cuff
Regulation Number: JOH
Classification Product Code: KXA
Date Received: 09/24/2012
Decision Date: 12/23/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
Manufacturer: JASON WALTON
Device Classification Name: Tube Tracheostomy And Tube Cuff
Regulation Number: JOH
Classification Product Code: KXA
Date Received: 09/24/2012
Decision Date: 12/23/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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