INSTRUMENT TRAY

General Surgery Tray

CUSH MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Cush Medical Products with the FDA for Instrument Tray.

Pre-market Notification Details

Device IDK935743
510k NumberK935743
Device Name:INSTRUMENT TRAY
ClassificationGeneral Surgery Tray
Applicant CUSH MEDICAL PRODUCTS P.O. BOX 247 881 MOUNTAIN VIEW DRIVE Piney Flats,  TN  37686
ContactSteve B Johnston
CorrespondentSteve B Johnston
CUSH MEDICAL PRODUCTS P.O. BOX 247 881 MOUNTAIN VIEW DRIVE Piney Flats,  TN  37686
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-01
Decision Date1994-03-03

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