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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
510(k) Number K043310
Device Name SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact LISA M BOYLE
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact LISA M BOYLE
Regulation Number878.4820
Classification Product Code
HWE  
Subsequent Product Codes
DZI   ERL   HBE  
Date Received12/01/2004
Decision Date 01/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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