NON-SKID SHOE COVERS

Cover, Shoe, Operating-room

ABCO DEALERS, INC.

The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Non-skid Shoe Covers.

Pre-market Notification Details

Device IDK872797
510k NumberK872797
Device Name:NON-SKID SHOE COVERS
ClassificationCover, Shoe, Operating-room
Applicant ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee,  WI  53218 -1238
ContactMolly Pribek
CorrespondentMolly Pribek
ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee,  WI  53218 -1238
Product CodeFXP  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-15
Decision Date1987-08-04

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