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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K960063
Device Name BOSWORTH IMPRESSION MATERIAL I
Applicant
Harry J. Bosworth Co.
7227 N. Hamlin Ave.
Skokie,  IL  60076
Applicant Contact JMILDRES M GOLDSTEIN
Correspondent
Harry J. Bosworth Co.
7227 N. Hamlin Ave.
Skokie,  IL  60076
Correspondent Contact JMILDRES M GOLDSTEIN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received01/05/1996
Decision Date 02/14/1996
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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