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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 K180237
Device Name Rezum System
Applicant
NxThera, Inc.
7351 Kirkwood Land North,
Suite 138
Maple Grove,  MN  55331
Applicant Contact Kathy Simpson
Correspondent
NxThera, Inc.
7351 Kirkwood Land North,
Suite 138
Maple Grove,  MN  55331
Correspondent Contact Kathy Simpson
Regulation Number876.4300
Classification Product Code
KNS  
Date Received01/29/2018
Decision Date 02/27/2018
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
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