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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K932699
Device Name ARTHREX AR-8200 SHAVER SYSTEM
Applicant
Arthrex, Inc.
3050 N. Horseshoe Dr.
Suite 200
Naples,  FL  33942
Applicant Contact BALTZ, JR
Correspondent
Arthrex, Inc.
3050 N. Horseshoe Dr.
Suite 200
Naples,  FL  33942
Correspondent Contact BALTZ, JR
Regulation Number878.4820
Classification Product Code
HWE  
Date Received06/03/1993
Decision Date 01/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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