Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back

Gown, Isolation, Surgical

Wildcat PPE, LLC

The following data is part of a premarket notification filed by Wildcat Ppe, Llc with the FDA for Wildcat Pe Surgical Isolation Gown Open Back, Wildcat Pe Surgical Isolation Gown Full Back.

Pre-market Notification Details

Device IDK202310
510k NumberK202310
Device Name:Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
ClassificationGown, Isolation, Surgical
Applicant Wildcat PPE, LLC 301 S. Trade Center Pkwy Conroe,  TX  77385
ContactMatthew Mcfarlane
CorrespondentMatthew Mcfarlane
Wildcat PPE, LLC 301 S. Trade Center Pkwy Conroe,  TX  77385
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-14
Decision Date2021-01-29

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