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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone grafting material, animal source
510(k) Number K091424
Device Name OSTA MAXIGRO AND REGIGRO
Applicant
OSTA TECHNOLOGIES
845 ARONSON LAKE COURT
ROSWELL,  GA  30075
Applicant Contact JAY MANSOUR
Correspondent
OSTA TECHNOLOGIES
845 ARONSON LAKE COURT
ROSWELL,  GA  30075
Correspondent Contact JAY MANSOUR
Regulation Number872.3930
Classification Product Code
NPM  
Date Received05/13/2009
Decision Date 08/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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