FORT DEFIANCE AUTOMATED STEAM STERILIZER

Sterilizer, Steam

Fort Defiance Industries, Inc.

The following data is part of a premarket notification filed by Fort Defiance Industries, Inc. with the FDA for Fort Defiance Automated Steam Sterilizer.

Pre-market Notification Details

Device IDK141009
510k NumberK141009
Device Name:FORT DEFIANCE AUTOMATED STEAM STERILIZER
ClassificationSterilizer, Steam
Applicant Fort Defiance Industries, Inc. 155 B Natalie BLVD Loudon,  TN  37774
ContactChris Yerger
CorrespondentChris Yerger
Fort Defiance Industries, Inc. 155 B Natalie BLVD Loudon,  TN  37774
Product CodeFLE  
CFR Regulation Number880.6880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-18
Decision Date2014-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00862992000334 K141009 000
00862992000327 K141009 000
00862992000310 K141009 000
00862992000303 K141009 000

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