CUSTOM STERILE PROCEDURE KITS

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STERILE DESIGN, INC.

The following data is part of a premarket notification filed by Sterile Design, Inc. with the FDA for Custom Sterile Procedure Kits.

Pre-market Notification Details

Device IDK842356
510k NumberK842356
Device Name:CUSTOM STERILE PROCEDURE KITS
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar,  FL  34677 -0137
ContactJohn C Hoffman
CorrespondentJohn C Hoffman
STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar,  FL  34677 -0137
Product Code510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-15
Decision Date1985-03-21

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