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510(k) K141009

FORT DEFIANCE AUTOMATED STEAM STERILIZER by Fort Defiance Industries, Inc. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2014
Date Received
April 18, 2014
Clearance Type
Traditional
Expedited Review
Yes
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

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