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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K070356
Device Name MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
Applicant
Medwaves Incorporated
16760 W Bernardo Dr.
San Diego,  CA  92127
Applicant Contact TED ORMSBY
Correspondent
Medwaves Incorporated
16760 W Bernardo Dr.
San Diego,  CA  92127
Correspondent Contact TED ORMSBY
Regulation Number878.4400
Classification Product Code
NEY  
Date Received02/06/2007
Decision Date 12/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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