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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
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 NumberS010
Date Received07/25/2016
Decision Date10/05/2016
Product Code
OAZ[ Registered Establishments with OAZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Revisions to the instructions for use and the patient manual to which clinical data from the post-approval study has been added.
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