TUXEDO VEST RESTRAINT

Restraint, Protective

DEROYAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Tuxedo Vest Restraint.

Pre-market Notification Details

Device IDK963474
510k NumberK963474
Device Name:TUXEDO VEST RESTRAINT
ClassificationRestraint, Protective
Applicant DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
ContactCamille Matlock
CorrespondentCamille Matlock
DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
Product CodeFMQ  
CFR Regulation Number880.6760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-03
Decision Date1997-01-22
Summary:summary

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