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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.
 
DeviceEBI BONE HEALING SYSTEM(R)
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Applicant
EBI, LLC
399 jefferson road
parsippany, NJ 07054
PMA NumberP790002
Supplement NumberS011
Date Received04/14/1989
Decision Date08/10/1989
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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