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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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