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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 K880295
Device Name CANNULA MODEL AR-6001
Applicant
Arthrex Arthroscopy Instruments, Inc.
121 Main St.
Norwalk,  CT  06851
Applicant Contact ROBERT B GANGNATH
Correspondent
Arthrex Arthroscopy Instruments, Inc.
121 Main St.
Norwalk,  CT  06851
Correspondent Contact ROBERT B GANGNATH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/25/1988
Decision Date 06/29/1988
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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