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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 K192597
Device Name Cytrans Granules
GC America, Inc.
3737 W. 127th St.
Alsip,  IL  60803
Applicant Contact Mark Heiss
Wood Burditt Group
10 E. Scranton Ave., Ste. 201
Lake Bluff,  IL  60045
Correspondent Contact H. Carl Jenkins
Regulation Number872.3930
Classification Product Code
Date Received09/20/2019
Decision Date 08/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No