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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 NORTH HAMLIN AVE.
SKOKIE,  IL  60076
Applicant Contact MILDRED M GOLDSTEIN
Correspondent
HARRY J. BOSWORTH CO.
7227 NORTH 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
Recalls CDRH Recalls
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