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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 K011102
Device Name ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
Original Applicant
AESCULAP, INC.
3773 corporate parkway
center valley,  PA  18034
Original Contact lisa m millington
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/11/2001
Decision Date 08/03/2001
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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