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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 NameHOLOGIC SAHARA CLINICAL BONE SONOMETER
Classification Namebone sonometer
Generic Nameacoustic bone densitometer
Regulation Number892.1180
ApplicantHOLOGIC, INC.
PMA NumberP970017
Supplement NumberS001
Date Received11/12/1998
Decision Date04/29/1999
Product Code
MUA[ Registered Establishments with MUA ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the manufacturing site to 35 crosby dr. , bedford, ma 01730.
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