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FDA 510(k) Application Details - K970907
Device Classification Name
Sterilizer, Steam
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510(K) Number
K970907
Device Name
Sterilizer, Steam
Applicant
GETINGE/CASTLE, INC.
1777 EAST HENRIETTA RD.
ROCHESTER, NY 14623-3133 US
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Contact
MICHAEL J PALLADINO
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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
03/11/1997
Decision Date
11/12/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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