RF Vapor System

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Aqua Medical, Inc.

The following data is part of a premarket notification filed by Aqua Medical, Inc. with the FDA for Rf Vapor System.

Pre-market Notification Details

Device IDK213627
510k NumberK213627
Device Name:RF Vapor System
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant Aqua Medical, Inc. 191 West Second St. Santa Ana,  CA  92701
ContactScott Mcgill
CorrespondentBosmat Friedman
ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte,  NC  28269
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-17
Decision Date2021-12-17

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