NON-STERILE ISOLATION GOWN

Gown, Isolation, Surgical

AMSCO STERILE RECOVERIES, INC.

The following data is part of a premarket notification filed by Amsco Sterile Recoveries, Inc. with the FDA for Non-sterile Isolation Gown.

Pre-market Notification Details

Device IDK931145
510k NumberK931145
Device Name:NON-STERILE ISOLATION GOWN
ClassificationGown, Isolation, Surgical
Applicant AMSCO STERILE RECOVERIES, INC. 28100 U.S. HWY, 19N., STE. 201 Clearwater,  FL  34621
ContactDenise A Schottler
CorrespondentDenise A Schottler
AMSCO STERILE RECOVERIES, INC. 28100 U.S. HWY, 19N., STE. 201 Clearwater,  FL  34621
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-05
Decision Date1994-06-10

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