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510(k) Premarket Notification Database

510(k) Premarket Notification Database
Device Classification Name: PLATE, FIXATION, BONE
Regulation Number: 888.3030
[See Other Products with this regulation number]
510(k) Number: K032032
Device Name: SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
Applicant: SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI, PA 19301
Contact: LISA M BOYLE
Product Code: HRS
[See Other Manufacturers that make this Product]
Date Received: 07-02-2003
Decision Date: 09-04-2003
Decision: SE
Advisory Committee: OR
Statement/Summary/Purged Status: Summary
Type: Traditional
Review by Third Party: N
Expedited Review: N
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