AMD Ritmed AssureWear VersaGown

Gown, Isolation, Surgical

AMD Medicom Inc.

The following data is part of a premarket notification filed by Amd Medicom Inc. with the FDA for Amd Ritmed Assurewear Versagown.

Pre-market Notification Details

Device IDK190306
510k NumberK190306
Device Name:AMD Ritmed AssureWear VersaGown
ClassificationGown, Isolation, Surgical
Applicant AMD Medicom Inc. 2555 Chemin De L'Aviation Pointe-claire, Montreal,  CA H9p 2z2
ContactRonald Reuben
CorrespondentNektaria Markoglou
AMD Medicom Inc. 2555 Chemin De L'Aviation Pointe-claire, Montreal,  CA H9p2z2
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-12
Decision Date2020-01-17

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