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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.
 
DeviceSURGICAL SIMPLEX BONE CEMENT
Classification Namebone cement
Generic Namebone cement
Regulation Number888.3027
Applicant
HOWMEDICA CORP.
359 veterans blvd.
rutherford, NJ 07070
PMA NumberN17003
Supplement NumberS001
Date Received03/03/1981
Decision Date11/13/1981
Product Code
LOD[ Registered Establishments with LOD ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
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