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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthopedic manual surgical instrument
510(k) Number K933242
Device Name SOFAMOR ORTHOPAEDIC INSTRUMENTS
Original Applicant
DANEK MEDICAL, INC.
3092 director's row
memphis,  TN  38131
Original Contact brian gooden
Regulation Number888.4540
Classification Product Code
LXH  
Date Received07/02/1993
Decision Date 01/28/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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