FDA 510(k) Application Details - K021504

Device Classification Name Sterilizer, Steam

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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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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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