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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 K213457
Device Name Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries 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 Received10/27/2021
Decision Date 03/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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