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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 OSTEOGEN BONE GROWTH STIMULATORS
Classification Namestimulator, invasive bone growth
Generic Namestimulator, invasive bone growth
Applicant
EBI, LLC
399 jefferson road
parsippany, NJ 07054
PMA NumberP790005
Supplement NumberS050
Date Received09/06/2013
Decision Date10/03/2013
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Physical Medicine
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of a new water system monitoring test method.
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