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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology
510(k) Number K123439
Device Name NEO ERCP GUIDEWIRE
Applicant
NEOMETRICS, INC.
2605 FERNBROOK LANE N.
SUITE J
PLYMOUTH,  MN  55447
Applicant Contact GENE CHAMPEAU
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number876.1500
Classification Product Code
OCY  
Date Received11/08/2012
Decision Date 01/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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