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FDA 510(k) Application Details - K030789
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K030789
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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More FDA Info for this Product Code
Date Received
03/12/2003
Decision Date
03/26/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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