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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dental barriers and sleeves
510(k) Number K132953
Device Name TIDISHEILD
Applicant
TIDI PRODUCTS, LLC
570 ENTERPRISE DR.
NEENAH,  WI  54956
Applicant Contact DION BRANDT
Correspondent
TIDI PRODUCTS, LLC
570 ENTERPRISE DR.
NEENAH,  WI  54956
Correspondent Contact DION BRANDT
Regulation Number878.4370
Classification Product Code
PEM  
Date Received09/20/2013
Decision Date 02/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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