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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
510(k) Number K935367
Device Name TAVA WIRE-DRIVER
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 Number878.4820
Classification Product Code
HSZ  
Date Received11/04/1993
Decision Date 04/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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