FDA 510(k) Application Details - K060066

Device Classification Name Indicator, Physical/Chemical Sterilization Process

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510(K) Number K060066
Device Name Indicator, Physical/Chemical Sterilization Process
Applicant ALBERT BROWNE LTD.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact CYNTHIA J M. NOLTE
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Regulation Number 880.2800

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Classification Product Code JOJ
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Date Received 01/09/2006
Decision Date 03/24/2006
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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