DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER

Endoscopic Tissue Approximation Device

DEROYAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Dosposable Enoscopic Hernia Surgical Stapler.

Pre-market Notification Details

Device IDK944435
510k NumberK944435
Device Name:DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER
ClassificationEndoscopic Tissue Approximation Device
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 CodeOCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-12
Decision Date1994-11-15

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