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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K243801
Device Name FRONT-LINE Field Sterilizer (FL135)
Applicant
Fort Defiance Industries, LLC
2411 Maremont Pkwy.
Loudon,  TN  37774
Applicant Contact Chris Coleman
Correspondent
Fort Defiance Industries, LLC
2411 Maremont Pkwy.
Loudon,  TN  37774
Correspondent Contact Chris Coleman
Regulation Number880.6880
Classification Product Code
FLE  
Date Received12/11/2024
Decision Date 03/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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