QUALTEX SUTURE BOOTIES

Instrument, Manual, Surgical, General Use

DEROYAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Qualtex Suture Booties.

Pre-market Notification Details

Device IDK911895
510k NumberK911895
Device Name:QUALTEX SUTURE BOOTIES
ClassificationInstrument, Manual, Surgical, General Use
Applicant DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
ContactDebra F.manning
CorrespondentDebra F.manning
DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
Product CodeMDM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-29
Decision Date1991-05-08

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