BARRIER SAF-TE HYDROGEL DRAPE

Drape, Surgical

JOHNSON & JOHNSON INTERNATIONAL

The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for Barrier Saf-te Hydrogel Drape.

Pre-market Notification Details

Device IDK922918
510k NumberK922918
Device Name:BARRIER SAF-TE HYDROGEL DRAPE
ClassificationDrape, Surgical
Applicant JOHNSON & JOHNSON INTERNATIONAL P.O. BOX 90130 2500 ARBROOK BLVD. Arlington,  TX  76004
ContactT. M Wendt
CorrespondentT. M Wendt
JOHNSON & JOHNSON INTERNATIONAL P.O. BOX 90130 2500 ARBROOK BLVD. Arlington,  TX  76004
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-18
Decision Date1993-07-06

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