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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K092292
Device Name CHECKPOINT
Applicant
NDI MEDICAL LLC
22901 MILLCREEK BOULEVARD
SUITE 110
CLEVELAND,  OH  44122
Applicant Contact JULIE GRILL
Correspondent
NDI MEDICAL LLC
22901 MILLCREEK BOULEVARD
SUITE 110
CLEVELAND,  OH  44122
Correspondent Contact JULIE GRILL
Regulation Number874.1820
Classification Product Code
ETN  
Date Received07/29/2009
Decision Date 10/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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