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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 K925996
Device Name ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES
Applicant
Arthrex, Inc.
3050 N. Horseshoe Dr.
Suite 200
Naples,  FL  33942
Applicant Contact LEONARD E BALTZ
Correspondent
Arthrex, Inc.
3050 N. Horseshoe Dr.
Suite 200
Naples,  FL  33942
Correspondent Contact LEONARD E BALTZ
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/27/1992
Decision Date 03/16/1993
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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