CONVERTORS SMS POLYOLEFIN GOWN

Gown, Surgical

ALLEGIANCE HEALTHCARE CORP.

The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Convertors Sms Polyolefin Gown.

Pre-market Notification Details

Device IDK020593
510k NumberK020593
Device Name:CONVERTORS SMS POLYOLEFIN GOWN
ClassificationGown, Surgical
Applicant ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park,  IL  60085
ContactSharon Robbins
CorrespondentSharon Robbins
ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park,  IL  60085
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-22
Decision Date2002-03-18
Summary:summary

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