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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 K041135
Device Name VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
Applicant
Depuy Mitek, A Johnson & Johnson Company
249 Vanderbilt Ave.
Norwood,  MA  02062
Applicant Contact RUTH C FORSTADT
Correspondent
Depuy Mitek, A Johnson & Johnson Company
249 Vanderbilt Ave.
Norwood,  MA  02062
Correspondent Contact RUTH C FORSTADT
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received04/30/2004
Decision Date 05/10/2004
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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