BOUNDARY SINGLE-USE GOWNS

Gown, Surgical

PROCTER & GAMBLE MFG. CO.

The following data is part of a premarket notification filed by Procter & Gamble Mfg. Co. with the FDA for Boundary Single-use Gowns.

Pre-market Notification Details

Device IDK834332
510k NumberK834332
Device Name:BOUNDARY SINGLE-USE GOWNS
ClassificationGown, Surgical
Applicant PROCTER & GAMBLE MFG. CO. 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 Received1983-12-12
Decision Date1984-05-01

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