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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 K023777
Device Name ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183
Applicant
Arthronet Medical, Inc.
8 Hammond, Suite 108
Irvine,  CA  92618
Applicant Contact CAROLINA SCHABER
Correspondent
Arthronet Medical, Inc.
8 Hammond, Suite 108
Irvine,  CA  92618
Correspondent Contact CAROLINA SCHABER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/12/2002
Decision Date 12/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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