FDA 510(k) Application Details - K052532

Device Classification Name Sterilizer, Steam

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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
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Regulation Number 880.6880

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Classification Product Code FLE
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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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