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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 K142397
Device Name Predicate III Guidewire
Applicant
Lake Region Medical
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact Mathew Pexa
Correspondent
Lake Region Medical
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact Mathew Pexa
Regulation Number876.1500
Classification Product Code
OCY  
Date Received08/27/2014
Decision Date 09/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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