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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name zinc oxide eugenol
510(k) Number K161630
Device Name Provicol QM Plus
Applicant
VOCO GMBH
ANTON-FLETTNER-STR. 1-3
CUXHAVEN,  DE 27472
Applicant Contact TH. PLAUMANN
Correspondent
VOCO GMBH
ANTON-FLETTNER-STR. 1-3
CUXHAVEN,  DE 27472
Correspondent Contact T. GERKENSMEIER
Regulation Number872.3275
Classification Product Code
EMB  
Date Received06/13/2016
Decision Date 09/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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