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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIO OSTEOGEN SYSTEM 204
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Applicant
EBI, LLC
399 jefferson road
parsippany, NJ 07054
PMA NumberP790002
Supplement NumberS002
Date Received07/15/1982
Decision Date08/20/1982
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
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