CUT RESISTANT GLOVE LINER

Accessory, Surgical Apparel

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Cut Resistant Glove Liner.

Pre-market Notification Details

Device IDK902633
510k NumberK902633
Device Name:CUT RESISTANT GLOVE LINER
ClassificationAccessory, Surgical Apparel
Applicant BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactLonnie Witham
CorrespondentLonnie Witham
BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeLYU  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-14
Decision Date1990-07-27

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