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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameOP-1 IMPLANT
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Applicant
Olympus Biotech Corporation
35 s. st.
hopkinton, MA 01748
HDE NumberH010002
Supplement NumberS011
Date Received12/08/2003
Decision Date04/02/2004
Product Code
MPW[ Registered Establishments with MPW ]
Docket Number 01M-0482
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
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