FDA 510(k) Application Details - K020747

Device Classification Name Sterilizer, Steam

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510(K) Number K020747
Device Name Sterilizer, Steam
Applicant STERIS Corporation
2424 WEST 23RD ST.
ERIE, PA 16506 US
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Contact LORI HALLER
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 03/07/2002
Decision Date 05/17/2002
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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