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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K000936
Device Name VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM
Applicant
Mitek Products
60 Glacier Dr.
Westwood,  MA  02090
Applicant Contact MARY P LEGRAW
Correspondent
Mitek Products
60 Glacier Dr.
Westwood,  MA  02090
Correspondent Contact MARY P LEGRAW
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/23/2000
Decision Date 04/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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