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FDA 510(k) Application Details - K021504
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K021504
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
TODD H HALPERN
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Regulation Number
880.6880
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Classification Product Code
FLE
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More FDA Info for this Product Code
Date Received
05/09/2002
Decision Date
07/25/2002
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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