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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 K141009
Device Name FORT DEFIANCE AUTOMATED STEAM STERILIZER
Applicant
Fort Defiance Industries, Inc.
155 B Natalie BLVD
Loudon,  TN  37774
Applicant Contact Chris Yerger
Correspondent
Fort Defiance Industries, Inc.
155 B Natalie BLVD
Loudon,  TN  37774
Correspondent Contact Chris Yerger
Regulation Number880.6880
Classification Product Code
FLE  
Date Received04/18/2014
Decision Date 12/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Recalls CDRH Recalls
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