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FDA 510(k) Application Details - K032192
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K032192
Device Name
Sterilizer, Steam
Applicant
TUTTNAUER USA CO. LTD.
1776 K STREET, N.W.
SUITE 800
WASHINGTON, DC 20006-7910 US
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Contact
MARK M YACURA
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
07/17/2003
Decision Date
08/12/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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