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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prophy Powder, Airbrush Accessory
510(k) Number K151748
Device Name Clean & More
Applicant
3M DEUTSCHLAND GMBH
ESPE PLATZ
SEEFELD,  DE 82234
Applicant Contact DESI W SOEGIARTO
Correspondent
3M DEUTSCHLAND GMBH
ESPE PLATZ
SEEFELD,  DE 82234
Correspondent Contact DESI W SOEGIARTO
Regulation Number872.6080
Classification Product Code
PIP  
Date Received06/29/2015
Decision Date 03/11/2016
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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