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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
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact LISA M MILLINGTON
Correspondent
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent 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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