ComfortGuard Surgical Isolation Gown

Gown, Isolation, Surgical

GRI-Alleset, Inc

The following data is part of a premarket notification filed by Gri-alleset, Inc with the FDA for Comfortguard Surgical Isolation Gown.

Pre-market Notification Details

Device IDK210131
510k NumberK210131
Device Name:ComfortGuard Surgical Isolation Gown
ClassificationGown, Isolation, Surgical
Applicant GRI-Alleset, Inc 4142 Industry Way Flowery Branch,  GA  30542
ContactMarty D Paugh
CorrespondentHarry L. Shaffer
Sterilization Consulting Services, LLC 7302 Kinglet Ct Katy,  TX  77493
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-08-26

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