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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 K922796
Device Name PELVIC C-CLAMP
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI,  PA  19301
Applicant Contact DIANE COCHET-WYNANT
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI,  PA  19301
Correspondent Contact DIANE COCHET-WYNANT
Regulation Number888.3040
Classification Product Code
JEC  
Date Received06/09/1992
Decision Date 03/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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