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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K132393
Device Name CERCOM II CEMENT
Applicant
Denali Corporation
134 Old Washington St.
Hanover,  MA  02339
Applicant Contact JAN G STANNARD
Correspondent
Denali Corporation
134 Old Washington St.
Hanover,  MA  02339
Correspondent Contact JAN G STANNARD
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/01/2013
Decision Date 03/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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