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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Battery-Powered
510(k) Number K062659
Device Name KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
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 Number886.4115
Classification Product Code
HQP  
Date Received09/07/2006
Decision Date 03/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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