C-SECTION TRAY

Kit, Surgical Instrument, Disposable

DEROYAL INDUSTRIES, INC.

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

Pre-market Notification Details

Device IDK842627
510k NumberK842627
Device Name:C-SECTION TRAY
ClassificationKit, Surgical Instrument, Disposable
Applicant DEROYAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKDD  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-06
Decision Date1984-09-26

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