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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K070360
Device Name KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
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
Classification Product Code
LFL  
Date Received02/07/2007
Decision Date 08/07/2007
Decision Substantially Equivalent (SESE)
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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