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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, Dc-Powered Motor And Accessory/Attachment
510(k) Number K944488
Device Name S & S ORTHOPEDIC WIRE DRIVER 701
Applicant
S & S Orthopedic , Ltd.
701 Westmont Dr.
Asheboro,  NC  27203
Applicant Contact FRANK SEFCIK
Correspondent
S & S Orthopedic , Ltd.
701 Westmont Dr.
Asheboro,  NC  27203
Correspondent Contact FRANK SEFCIK
Regulation Number878.4820
Classification Product Code
KIJ  
Subsequent Product Code
GFC  
Date Received09/13/1994
Decision Date 03/02/1995
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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