QUALTEX NEUROLOK SURGICAL SPONGE

Gauze/sponge, Internal, X-ray Detectable

DEROYAL INDUSTRIES, INC.

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

Pre-market Notification Details

Device IDK884790
510k NumberK884790
Device Name:QUALTEX NEUROLOK SURGICAL SPONGE
ClassificationGauze/sponge, Internal, X-ray Detectable
Applicant DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
ContactWyatt Zachry
CorrespondentWyatt Zachry
DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
Product CodeGDY  
CFR Regulation Number878.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-15
Decision Date1988-12-09

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