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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 NumberS013
Date Received06/27/2022
Decision Date07/27/2022
Product Code
OAZ[ Registered Establishments with OAZ ]
Advisory Committee Anesthesiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
A minor change to a manufacturing tool used in the assembly of the svs deployment catheter and loader.
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