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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 avenue ne
redmond, WA 98052
HDE NumberH060002
Supplement NumberS006
Date Received07/28/2014
Decision Date12/16/2014
Product Code
OAZ[ Registered Establishments with OAZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the post-approval study protocol.
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