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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 K010677
Device Name XPS 3000 SYSTEM
Applicant
Medtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact MARTIN D SARGENT
Correspondent
Medtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact MARTIN D SARGENT
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/07/2001
Decision Date 05/07/2001
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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