MDRWeb Medical Device Register On-line from Canon Communications, LLC

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510(k) Premarket Notification Database

Device Classification Name:
Regulation Number:	[See Other Products with this regulation number]
510(k) Number:	K031785
Device Name:	MACROPORE CARDIO-WRAP (TS)
Applicant:	MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. SAN DIEGO, CA 92121
Contact:	KENNETH K KLEINHENZ
Product Code:	OMH [See Other Manufacturers that make this Product]
Date Received:	06-10-2003
Decision Date:	09-04-2003
Decision:	SE
Advisory Committee:	CV
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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