STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV

Gown, Surgical

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Sterile View Disp. Hood/gown Uv, Barrier Hood, Uv.

Pre-market Notification Details

Device IDK901536
510k NumberK901536
Device Name:STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV
ClassificationGown, Surgical
Applicant DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactMelinda A Wright
CorrespondentMelinda A Wright
DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-02
Decision Date1990-11-29

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