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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 K900136
Device Name CEROS 80 (HA)
Applicant
Mathys Corp.
7 Great Valley Pkwy.
Suite 223
Malvern,  PA  19355
Applicant Contact HEINZ WICK
Correspondent
Mathys Corp.
7 Great Valley Pkwy.
Suite 223
Malvern,  PA  19355
Correspondent Contact HEINZ WICK
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/10/1990
Decision Date 01/29/1991
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
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