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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Central Control Unit
510(k) Number K151282
Device Name core nova Complete Operating Room Endoscopy
Applicant
Richard Wolf Medical Instruments Corp.
353 Corporate Woods Pkwy.
Vernon Hills,  IL  60061
Applicant Contact MICHELE MCDONALD
Correspondent
Richard Wolf Medical Instruments Corp.
353 Corporate Pkwy.
Vernon Hills,  IL  60061
Correspondent Contact Lisa Williams
Regulation Number876.1500
Classification Product Code
ODA  
Date Received05/14/2015
Decision Date 01/12/2016
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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