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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K043170
Device Name BOSWORTH BOND
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 Number872.3200
Classification Product Code
KLE  
Date Received11/16/2004
Decision Date 02/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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