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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 K992876
Device Name VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
Applicant
Mitek Products
60 Glacier Dr.
Westwood,  MA  02090
Applicant Contact PAULA E BULGER
Correspondent
Mitek Products
60 Glacier Dr.
Westwood,  MA  02090
Correspondent Contact PAULA E BULGER
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received08/26/1999
Decision Date 09/24/1999
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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