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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 K030096
Device Name VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW
Applicant
Arthrex, Inc.
2885 S. Horseshoe Dr.
Naples,  FL  34104
Applicant Contact SALLY FOUST
Correspondent
Arthrex, Inc.
2885 S. Horseshoe Dr.
Naples,  FL  34104
Correspondent Contact SALLY FOUST
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/10/2003
Decision Date 03/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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