FDA 510(k) Application Details - K141009

Device Classification Name Sterilizer, Steam

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510(K) Number K141009
Device Name Sterilizer, Steam
Applicant Fort Defiance Industries, Inc.
155 B Natalie BLVD
Loudon, TN 37774 US
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Contact Chris Yerger
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 04/18/2014
Decision Date 12/16/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review Y

FDA Source Information for K141009


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