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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K940673
Device Name J.B.S. SELF-TAPPING THREADED PIN
Applicant
J.B.S., S.A.
391 Menhaden Ct.
Foster City,  CA  94404
Applicant Contact HARTMUT H LOCH
Correspondent
J.B.S., S.A.
391 Menhaden Ct.
Foster City,  CA  94404
Correspondent Contact HARTMUT H LOCH
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
JDW  
Date Received02/16/1994
Decision Date 11/14/1994
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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