FDA 510(k) Application Details - K140736

Device Classification Name Sterilizer, Steam

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510(K) Number K140736
Device Name Sterilizer, Steam
Applicant MILTON E PEDRAZZI D.D.S., INC.
6501 CROWN BLVD, SUITE 102
SAN JOSE, CA 95120 US
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Contact MILTON E PEDRAZZI DDS
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 03/24/2014
Decision Date 01/20/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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