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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 K150786
Device Name Rezum System
NxThera, Inc.
7351 Kirkwood Lane N.
maple grove,  MN  55369
Applicant Contact j. robert paulson, jd
Libra Medical Inc.
8401 73rd Avenue North, Suite 63
brooklyn park,  MN  55428
Correspondent Contact sew-wah tay
Regulation Number876.4300
Classification Product Code
Date Received03/25/2015
Decision Date 08/27/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Clinical Trials NCT01912339
Reviewed by Third Party No
Combination Product No