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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 K150225
Device Name NovaGold High Performance Guidewire
Applicant
Neometrics, Inc.
2605 Fernbrook Ln. N., Suite J
Plymouth,  MN  55447
Applicant Contact Dave Liebl
Correspondent
Neometrics, Inc.
2605 Fernbrook Ln. N., Suite J
Plymouth,  MN  55447
Correspondent Contact Dave Liebl
Regulation Number876.1500
Classification Product Code
OCY  
Date Received02/02/2015
Decision Date 03/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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