CARDIAC SUPPLY TRAY

Catheter, Percutaneous

DEROYAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Cardiac Supply Tray.

Pre-market Notification Details

Device IDK842645
510k NumberK842645
Device Name:CARDIAC SUPPLY TRAY
ClassificationCatheter, Percutaneous
Applicant DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
ContactSusan Hevey
CorrespondentSusan Hevey
DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-10
Decision Date1984-08-27

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