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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 K011335
Device Name SYNTHS ONE-THIRD TUBULAR DCL PLATE
Applicant
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI,  PA  19301 -1222
Applicant Contact MATTHEW M HULL
Correspondent
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI,  PA  19301 -1222
Correspondent Contact MATTHEW M HULL
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/02/2001
Decision Date 07/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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