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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K832277
Device Name ACUFLEX LEVY ACL DRILL GUIDE SYS
Applicant
Acufex Microsurgical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Acufex Microsurgical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/12/1983
Decision Date 08/16/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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