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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 STREET
HANOVER,  MA  02339
Applicant Contact Jan G Stannard
Correspondent
DENALI CORPORATION
134 OLD WASHINGTON STREET
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
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