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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, operative dental
510(k) Number K141504
Device Name T-8000 THEROZONE UNIT
Applicant
THEROZONE USA, INC.
2701 OCEAN PARK BLVD, SUITE 108
SANTA MONICA,  CA  90405
Applicant Contact Rebecca K Pine
Correspondent
THEROZONE USA, INC.
2701 OCEAN PARK BLVD, SUITE 108
SANTA MONICA,  CA  90405
Correspondent Contact Rebecca K Pine
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/06/2014
Decision Date 02/24/2015
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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