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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K092580
Device Name TIDI FACEMASK
Applicant
TIDI PRODUCTS,LLC
570 ENTERPRISE DR.
NEENAH,  WI  54956
Applicant Contact DION J BRANDT
Correspondent
TIDI PRODUCTS,LLC
570 ENTERPRISE DR.
NEENAH,  WI  54956
Correspondent Contact DION J BRANDT
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/21/2009
Decision Date 02/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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