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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameSPIRATION VALVE SYSTEM (INCLUDING AIRWAY SIZING KIT)
Classification Nameone-way air-leak valve
Generic Nameone-way air-leak valve
Applicant
Gyrus Acmi, Inc.
6675 185th ave. ne
redmond, WA 98052
HDE NumberH060002
Supplement NumberS009
Date Received11/27/2015
Decision Date12/22/2015
Product Code
OAZ[ Registered Establishments with OAZ ]
Advisory Committee Anesthesiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the addition of a contraindication and changes in the instructions for use.
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