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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 K021504
Device Name TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
Original Applicant
TUTTNAUER USA CO. LTD.
1776 k street, n.w.
suite 800
washington,  DC  20006 7910
Original Contact todd h halpern
Regulation Number880.6880
Classification Product Code
FLE  
Date Received05/09/2002
Decision Date 07/25/2002
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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