STERILE STOCKINETTE W/ANTIMICROBIAL AGENT

Drape, Surgical

DEROYAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Sterile Stockinette W/antimicrobial Agent.

Pre-market Notification Details

Device IDK861196
510k NumberK861196
Device Name:STERILE STOCKINETTE W/ANTIMICROBIAL AGENT
ClassificationDrape, Surgical
Applicant DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
ContactSusan N Hevey
CorrespondentSusan N Hevey
DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell,  TN  37849
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-31
Decision Date1986-04-30

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