SRI PLR GOWN

Gown, Surgical

SRI/SURGICAL EXPRESS

The following data is part of a premarket notification filed by Sri/surgical Express with the FDA for Sri Plr Gown.

Pre-market Notification Details

Device IDK080707
510k NumberK080707
Device Name:SRI PLR GOWN
ClassificationGown, Surgical
Applicant SRI/SURGICAL EXPRESS P.O. BOX 92493 Austin,  TX  78709
ContactJeffrey O Stull
CorrespondentJeffrey O Stull
SRI/SURGICAL EXPRESS P.O. BOX 92493 Austin,  TX  78709
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-12
Decision Date2008-11-13

NIH GUDID Devices

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