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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K160417
Device Name Rezum System
Applicant
Nxthera, Inc.
7351 Kirkwood Lane N.
Suite 138
Maple Grove,  MN  55369
Applicant Contact J. Robert Paulson
Correspondent
Libramedical, Inc.
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Correspondent Contact Julie Bodmer
Regulation Number876.4300
Classification Product Code
KNS  
Date Received02/16/2016
Decision Date 03/17/2016
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
Recalls CDRH Recalls
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