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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Cleaning Solution
510(k) Number K152322
Device Name Resolve 2.0
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 Number872.3260
Classification Product Code
PME  
Date Received08/17/2015
Decision Date 12/16/2015
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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