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FDA 510(k) Application Details - K141009
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K141009
Device Name
Sterilizer, Steam
Applicant
Fort Defiance Industries, Inc.
155 B Natalie BLVD
Loudon, TN 37774 US
Other 510(k) Applications for this Company
Contact
Chris Yerger
Other 510(k) Applications for this Contact
Regulation Number
880.6880
More FDA Info for this Regulation Number
Classification Product Code
FLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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