Aqua Medical 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 Aqua Medical Rf Vapor System.

Pre-market Notification Details

Device IDK183595
510k NumberK183595
Device Name:Aqua Medical RF Vapor System
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant Aqua Medical, Inc. 191 West Second St. Santa Ana,  CA  92701
ContactLloyd Mencinger
CorrespondentBosmat Friedman
ProMedoss, Inc. 3521 Hatwynn Rd Charlotte,  NC  28269
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-21
Decision Date2019-06-21

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