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510(k) Premarket Notification Database

Device Classification Name:	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Regulation Number:	888.3560 [See Other Products with this regulation number]
510(k) Number:	K031729
Device Name:	TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
Applicant:	HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH ALLENDALE, NJ 07401 1677
Contact:	MARGARET F CROWE
Product Code:	JWH [See Other Manufacturers that make this Product]
Date Received:	06-04-2003
Decision Date:	09-02-2003
Decision:	SE
Advisory Committee:	OR
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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