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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 K811101
Device Name HYDROXYLAPATITE
Applicant
CARBOMEDICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CARBOMEDICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.3930
Classification Product Code
LYC  
Date Received04/21/1981
Decision Date 11/20/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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