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FDA 510(k) Application Details - K060066
Device Classification Name
Indicator, Physical/Chemical Sterilization Process
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.2800
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Classification Product Code
JOJ
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More FDA Info for this Product Code
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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