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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestimulator, bone growth, non-invasive
Generic Namebone growth stimulator
ApplicantDJO, LLC
PMA NumberP910066
Date Received11/18/1991
Decision Date03/04/1994
Product Code
LOF[ Registered Establishments with LOF ]
Docket Number 94M-0128
Notice Date 05/20/1994
Advisory Committee Physical Medicine
Expedited Review Granted? No
Combination Product No
Supplements: S002 S004 S005 S007 S008 S009 S011 S012 S013 
S014 S015 S016 S017 S019 S020 S021 S022 S023 
S024 S025 S026 S027