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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name barrier, animal source, intraoral
510(k) Number K223912
Device Name InterCollagen® Guide
SigmaGraft Inc.
575 Sally Place
Fullerton,  CA  92831
Applicant Contact Elcin Chang
SigmaGraft Inc.
575 Sally Place
Fullerton,  CA  92831
Correspondent Contact Elcin Chang
Regulation Number872.3930
Classification Product Code
Date Received12/29/2022
Decision Date 08/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No