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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K852868
Device Name WUNDERSHADE
Applicant
Harry J. Bosworth Co.
7227 N. Hamlin Ave.
Skokie,  IL  60076
Applicant Contact GOLDSTEIN
Correspondent
Harry J. Bosworth Co.
7227 N. Hamlin Ave.
Skokie,  IL  60076
Correspondent Contact GOLDSTEIN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received07/08/1985
Decision Date 09/27/1985
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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