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510(k) Premarket Notification Database

Device Classification Name:	SEALANT, PIT AND FISSURE, AND CONDITIONER, RESIN
Regulation Number:	872.3765 [See Other Products with this regulation number]
510(k) Number:	K031811
Device Name:	PIT & FISSURE SEALANT WITH FLUORIDE
Applicant:	HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. SKOKIE, IL 60076
Contact:	MILDRED M GOLDSTEIN
Product Code:	EBC [See Other Manufacturers that make this Product]
Date Received:	06-18-2003
Decision Date:	09-04-2003
Decision:	SE
Advisory Committee:	DE
Statement/Summary/Purged Status:	Statement
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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