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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K100912
Device Name DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
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 Number882.1350
Classification Product Code
GXZ  
Date Received04/01/2010
Decision Date 08/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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