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FDA 510(k) Application Details - K953938
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K953938
Device Name
Sterilizer, Steam
Applicant
BARNSTEAD/THERMOLYNE CORP.
2555 KERPER BLVD.
DUBUQUE, IA 52001 US
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Contact
CRAIG T CASE
Other 510(k) Applications for this Contact
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
08/21/1995
Decision Date
01/30/1997
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
N
Expedited Review
FDA Source Information for K953938
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