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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 PMA to get an up-to-date view of this device.
 
Trade NameQUS-2 CALCANEAL ULTRASONOMETER
Classification Nametester,acoustic,bone quality
Generic Namebone ultrasonometer
ApplicantQUIDEL CORP.
PMA NumberP990039
Supplement NumberS001
Date Received04/14/2003
Decision Date06/19/2003
Product Code
NAN
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility located at plexus ea, seattle, bothell, wa.
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