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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 K101426
Device Name CEROS TCP GRANULES
Applicant
MATHYS LTD
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130 -8587
Applicant Contact LINDA SCHULZ
Correspondent
MATHYS LTD
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130 -8587
Correspondent Contact LINDA SCHULZ
Regulation Number872.3930
Classification Product Code
LYC  
Date Received05/21/2010
Decision Date 09/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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