SURGICAL DRAPE AND GOWN TRAY

Gown, Surgical

CUSTOM MEDICAL PRODUCTS, LTD.

The following data is part of a premarket notification filed by Custom Medical Products, Ltd. with the FDA for Surgical Drape And Gown Tray.

Pre-market Notification Details

Device IDK931456
510k NumberK931456
Device Name:SURGICAL DRAPE AND GOWN TRAY
ClassificationGown, Surgical
Applicant CUSTOM MEDICAL PRODUCTS, LTD. P.O. BOX 8875 Asheville,  NC  28814
ContactCarolann Kotula-cook
CorrespondentCarolann Kotula-cook
CUSTOM MEDICAL PRODUCTS, LTD. P.O. BOX 8875 Asheville,  NC  28814
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-23
Decision Date1994-07-08

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