DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS

Pack, Hot Or Cold, Disposable

DEROYAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Industries, Inc. Infant Transport Mattress.

Pre-market Notification Details

Device IDK980509
510k NumberK980509
Device Name:DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
ClassificationPack, Hot Or Cold, Disposable
Applicant DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
ContactCamille Matlock
CorrespondentCamille Matlock
DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
Product CodeIMD  
CFR Regulation Number890.5710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-10
Decision Date1998-02-26
Summary:summary

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