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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
Predetermined Change
Control Plan Authorized		 No
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