DISPOSABLE SURGICAL GARMENTS

Gown, Surgical

ALPHAMEDIX, INC.

The following data is part of a premarket notification filed by Alphamedix, Inc. with the FDA for Disposable Surgical Garments.

Pre-market Notification Details

Device IDK820363
510k NumberK820363
Device Name:DISPOSABLE SURGICAL GARMENTS
ClassificationGown, Surgical
Applicant ALPHAMEDIX, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-02-09
Decision Date1982-03-08

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