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FDA 510(k) Application Details - K052532
Device Classification Name
Sterilizer, Steam
More FDA Info for this Device
510(K) Number
K052532
Device Name
Sterilizer, Steam
Applicant
DENTAL X SRL
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact
CYNTHIA J.M. NOLTE
Other 510(k) Applications for this Contact
Regulation Number
880.6880
More FDA Info for this Regulation Number
Classification Product Code
FLE
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More FDA Info for this Product Code
Date Received
09/15/2005
Decision Date
09/05/2006
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
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