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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 NamePEPGEN-P15
Classification Namebone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantCERAMED CORP.
PMA NumberP990033
Supplement NumberS001
Date Received11/08/1999
Decision Date01/27/2000
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval is for a new sterilization facility located at steris-isomedix services, 9120 south 150 east, sandy, utah.
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