BARRIER SURGICAL GOWNS

Gown, Surgical

JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Medical, Div. Of Ethicon, Inc. with the FDA for Barrier Surgical Gowns.

Pre-market Notification Details

Device IDK990395
510k NumberK990395
Device Name:BARRIER SURGICAL GOWNS
ClassificationGown, Surgical
Applicant JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. 2500 EAST ARBROOK BLVD. Arlington,  TX  76014 -3631
ContactJane Ann Martin
CorrespondentJane Ann Martin
JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. 2500 EAST ARBROOK BLVD. Arlington,  TX  76014 -3631
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-09
Decision Date1999-04-13
Summary:summary

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