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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy
510(k) Number K160077
Device Name RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
Applicant
JBW7 Innovations, LLC
22200 W. 11 Mile Road, # 4182
Southfield,  MI  48037
Applicant Contact Jason B Wynberg
Correspondent
JBW7 Innovations, LLC
22200 W. 11 Mile Road, # 4182
Southfield,  MI  48037
Correspondent Contact Jason B Wynberg
Classification Product Code
LJE  
Date Received01/14/2016
Decision Date 07/12/2016
Decision Substantially Equivalent (SESE)
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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