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510(k) Premarket Notification Database

Device Classification Name:	MARKER, RADIOGRAPHIC, IMPLANTABLE
Regulation Number:	878.4300 [See Other Products with this regulation number]
510(k) Number:	K031938
Device Name:	GEL MARK III BIOPSY SITE MARKER
Applicant:	SENORX, INC. 11 COLUMBIA, SUITE A ALISO VIEJO, CA 92656
Contact:	AMY BOUCLY
Product Code:	NEU [See Other Manufacturers that make this Product]
Date Received:	06-23-2003
Decision Date:	09-05-2003
Decision:	SE
Advisory Committee:	SU
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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