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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 K151209
Device Name InterOss
Applicant
SigmaGraft, Inc
335 N. Puente St.
Unit A
Brea,  CA  92821
Applicant Contact Megan Holden
Correspondent
SigmaGraft, Inc
335 N. Puente St.
Unit A
Brea,  CA  92821
Correspondent Contact Megan Holden
Regulation Number872.3930
Classification Product Code
NPM  
Date Received05/06/2015
Decision Date 11/06/2015
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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