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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K940207
Device Name TITANIUM ALLOY BONE SCREWS
Original Applicant
AESCULAP, INC.
1000 gateway blvd.
south san francisco,  CA  94080
Original Contact victoria mackinnon
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/14/1994
Decision Date 07/12/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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