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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 K031406
Device Name EXOJET TISSUE MANAGEMENT SYSTEM
Applicant
Mitek Worldwide
A Johnson & Johnson Company
249 Vanderbilt Ave.
Norwood,  MA  02062
Applicant Contact SERGIO J GADALETA
Correspondent
Mitek Worldwide
A Johnson & Johnson Company
249 Vanderbilt Ave.
Norwood,  MA  02062
Correspondent Contact SERGIO J GADALETA
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/05/2003
Decision Date 05/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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