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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 K940109
Device Name TAVA K-WIRE
Applicant
Tava Surgical Instruments
1715 Surveyor Ave.
Simi Valley,  CA  93063
Applicant Contact DAVID VANDERHORST
Correspondent
Tava Surgical Instruments
1715 Surveyor Ave.
Simi Valley,  CA  93063
Correspondent Contact DAVID VANDERHORST
Regulation Number888.3040
Classification Product Code
HTY  
Date Received01/10/1994
Decision Date 02/22/1994
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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