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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K970280
Device Name FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES
Applicant
FERGUSON MEDICAL
3407 BAY AVE.
CHICO,  CA  95973 -8619
Applicant Contact FRANK FERGUSON
Correspondent
FERGUSON MEDICAL
3407 BAY AVE.
CHICO,  CA  95973 -8619
Correspondent Contact FRANK FERGUSON
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
HRS  
Date Received01/23/1997
Decision Date 05/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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