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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K960782
Device Name TITANIUM TUBE TO TUBE CLAMP
Applicant
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301 -1222
Applicant Contact ANGELA J SILVESTRI
Correspondent
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301 -1222
Correspondent Contact ANGELA J SILVESTRI
Regulation Number888.3040
Classification Product Code
JEC  
Date Received02/26/1996
Decision Date 05/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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