FDA 510(k) Application Details - K022816

Device Classification Name Sterilizer, Steam

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510(K) Number K022816
Device Name Sterilizer, Steam
Applicant A-DEC, INC.
2601 CRESTVIEW DR.
NEWBERG, OR 97132-9257 US
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Contact TOM LOUISELL
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 08/26/2002
Decision Date 02/07/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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