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FDA 510(k), K093126, ANAPNOGUARD ENDOTRACHEAL TUBE
FDA 510(k), K093126, ANAPNOGUARD ENDOTRACHEAL TUBE
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510(K) Number: K093126
Device Name: ANAPNOGUARD ENDOTRACHEAL TUBE
Manufacturer: YORAM LEVY
Device Classification Name: Dropper, Ether
Regulation Number: BTP
Classification Product Code: KXA
Date Received: 10/02/2009
Decision Date: 03/02/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: ANAPNOGUARD ENDOTRACHEAL TUBE
Manufacturer: YORAM LEVY
Device Classification Name: Dropper, Ether
Regulation Number: BTP
Classification Product Code: KXA
Date Received: 10/02/2009
Decision Date: 03/02/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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