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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K000066
Device Name SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI,  PA  19301
Applicant Contact SHERI L MUSGNUNG
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI,  PA  19301
Correspondent Contact SHERI L MUSGNUNG
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTY   HWC   JDW  
Date Received01/10/2000
Decision Date 03/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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