STERILE SURGEON'S GOWN

Gown, Surgical

AMSCO STERILE RECOVERIES, INC.

The following data is part of a premarket notification filed by Amsco Sterile Recoveries, Inc. with the FDA for Sterile Surgeon's Gown.

Pre-market Notification Details

Device IDK920405
510k NumberK920405
Device Name:STERILE SURGEON'S GOWN
ClassificationGown, Surgical
Applicant AMSCO STERILE RECOVERIES, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck,  NY  11201
ContactCarolann Dotula-cook
CorrespondentCarolann Dotula-cook
AMSCO STERILE RECOVERIES, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck,  NY  11201
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-31
Decision Date1992-08-18

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