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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 NameORTHOPAK(R) BONE GROWTH STIMULATOR
Classification Namestimulator, bone growth, non-invasive
Generic Namenon-invasive bone growth stimulator
ApplicantBIOLECTRON, INC.
PMA NumberP850022
Supplement NumberS008
Date Received10/05/1992
Decision Date08/06/1993
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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