FAR-EAST BARRIER GOWNS

Gown, Isolation, Surgical

FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD

The following data is part of a premarket notification filed by Far East Science & Technology Development Co., Ltd with the FDA for Far-east Barrier Gowns.

Pre-market Notification Details

Device IDK971702
510k NumberK971702
Device Name:FAR-EAST BARRIER GOWNS
ClassificationGown, Isolation, Surgical
Applicant FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD 11250 DALE ST. #59 Garden Grove,  CA  92841
ContactDavid Song
CorrespondentDavid Song
FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD 11250 DALE ST. #59 Garden Grove,  CA  92841
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-08
Decision Date1997-07-08

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