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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Dental, Intraoral
510(k) Number K854530
Device Name PREMIUM FLEXI-TOUGH
Applicant
The Hygenic Corp.
1245 Home Ave.
Akron,  OH  44310 -2575
Applicant Contact MEYER
Correspondent
The Hygenic Corp.
1245 Home Ave.
Akron,  OH  44310 -2575
Correspondent Contact MEYER
Regulation Number872.6890
Classification Product Code
EGD  
Date Received11/13/1985
Decision Date 03/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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