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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 NameIBV 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 NumberS001
Date Received01/12/2009
Decision Date11/27/2009
Product Code
OAZ[ Registered Establishments with OAZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 75 day track
Supplement Reason other report
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the post-approval study protocol.
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