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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 K052203
Device Name AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600
Applicant
Kirwan Surgical Products, Inc.
180 Enterprise Dr.
Marshfield,  MA  02050
Applicant Contact KEVIN P PRARIO
Correspondent
Kirwan Surgical Products, Inc.
180 Enterprise Dr.
Marshfield,  MA  02050
Correspondent Contact KEVIN P PRARIO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/12/2005
Decision Date 10/20/2005
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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