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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 K981416
Device Name MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15
Applicant
Magna Advanced Technologies, Inc.
7200 NW Seventh St.
2nd Floor
Miami,  FL  33126
Applicant Contact ANNIE VELEZ
Correspondent
Magna Advanced Technologies, Inc.
7200 NW Seventh St.
2nd Floor
Miami,  FL  33126
Correspondent Contact ANNIE VELEZ
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/20/1998
Decision Date 06/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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