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510(k) Premarket Notification Database

Device Classification Name:	PLATE, BONE, ORTHODONTIC
Regulation Number:	872.4760 [See Other Products with this regulation number]
510(k) Number:	K031761
Device Name:	SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
Applicant:	SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 PAOLI, PA 19301
Contact:	LISA BOYLE
Product Code:	JEY [See Other Manufacturers that make this Product]
Date Received:	06-06-2003
Decision Date:	09-03-2003
Decision:	SE
Advisory Committee:	DE
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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