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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K933505
Device Name BOSWORTH COPALIONER
Applicant
Harry J. Bosworth Co.
7227 N. Hamlin Ave.
Skokie,  IL  60076
Applicant Contact MILDRED M GOLDSTEIN
Correspondent
Harry J. Bosworth Co.
7227 N. Hamlin Ave.
Skokie,  IL  60076
Correspondent Contact MILDRED M GOLDSTEIN
Regulation Number872.3260
Classification Product Code
LBH  
Date Received07/15/1993
Decision Date 01/07/1994
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
Recalls CDRH Recalls
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