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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sealant, pit and fissure, and conditioner
510(k) Number K033751
Device Name AEGIS PIT & FISSURE SEALANT WITH ACP
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 Number872.3765
Classification Product Code
EBC  
Date Received12/01/2003
Decision Date 02/05/2004
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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