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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 K213627
Device Name RF Vapor System
Aqua Medical, Inc.
191 West Second St.
Santa Ana,  CA  92701
Applicant Contact Scott McGill
ProMedoss, Inc.
3521 Hatwynn Rd.
Charlotte,  NC  28269
Correspondent Contact Bosmat Friedman
Regulation Number876.4300
Classification Product Code
Subsequent Product Code
Date Received11/17/2021
Decision Date 12/17/2021
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