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FDA 510(k) Application Details - K100622
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K100622
Device Name
Sterilizer, Steam
Applicant
BELIMED SAUTER AG
ZELGSTRASSE 8
SULGEN (TG) CH-8583 CH
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Contact
HANS STADLER
Other 510(k) Applications for this Contact
Regulation Number
880.6880
More FDA Info for this Regulation Number
Classification Product Code
FLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/04/2010
Decision Date
08/27/2010
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
Y
Expedited Review
FDA Source Information for K100622
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