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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 NameGEL-ONE
Classification Nameacid, hyaluronic, intraarticular
ApplicantSEIKAGAKU CORP.
PMA NumberP080020
Supplement NumberS007
Date Received05/01/2014
Decision Date05/30/2014
Product Code
MOZ[ Registered Establishments with MOZ ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of two new raw material storage rooms.
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