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510(k) Premarket Notification Database

Device Classification Name:	DURA-SUBSTITUTE
Regulation Number:	882.5910 [See Other Products with this regulation number]
510(k) Number:	K031850
Device Name:	DURASIS DURAL SUBSTITUTE
Applicant:	COOK BIOTECH, INC. 3055 KENT AVE. WEST LAFAYETTE, IN 47906 1076
Contact:	MARK BLEYER
Product Code:	GXQ [See Other Manufacturers that make this Product]
Date Received:	06-19-2003
Decision Date:	09-08-2003
Decision:	SE
Advisory Committee:	NE
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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