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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
Applicant
Aqua Medical, Inc.
191 W. Second St.
Santa Ana,  CA  92701
Applicant Contact Scott McGill
Correspondent
ProMedoss, Inc.
3521 Hatwynn Rd.
Charlott,  NC  28269
Correspondent Contact Bosmat Friedman
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Code
GEI  
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
Predetermined Change
Control Plan Authorized		 No
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