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FDA 510(k) Application Details - K022816
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.6880
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Classification Product Code
FLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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