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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, Synthetic
510(k) Number K102208
Device Name NANOGEN
Applicant
ORTHOGEN, LLC
505 MORRIS AVENUE,
SUITE 104
SPRINGFIELD,  NJ  07081
Applicant Contact HAROLD ALEXANDER
Correspondent
ORTHOGEN, LLC
505 MORRIS AVENUE,
SUITE 104
SPRINGFIELD,  NJ  07081
Correspondent Contact HAROLD ALEXANDER
Regulation Number872.3930
Classification Product Code
LYC  
Date Received08/05/2010
Decision Date 05/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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