STERISURE STERILIZATION WRAP

Wrap, Sterilization

FIBERWEB NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Fiberweb North America, Inc. with the FDA for Sterisure Sterilization Wrap.

Pre-market Notification Details

Device IDK944854
510k NumberK944854
Device Name:STERISURE STERILIZATION WRAP
ClassificationWrap, Sterilization
Applicant FIBERWEB NORTH AMERICA, INC. 840 SOUTH EAST MAIN ST. Simpsonville,  SC  29681
ContactCornelius A Cunningham
CorrespondentCornelius A Cunningham
FIBERWEB NORTH AMERICA, INC. 840 SOUTH EAST MAIN ST. Simpsonville,  SC  29681
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-30
Decision Date1994-12-19

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