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FDA 510(k) Application Details - K965154
Device Classification Name
Indicator, Sterilization
More FDA Info for this Device
510(K) Number
K965154
Device Name
Indicator, Sterilization
Applicant
ALBERT BROWNE LTD.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact
CYNTHIA J.M. NOLTE, PH.D.
Other 510(k) Applications for this Contact
Regulation Number
880.2800
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Classification Product Code
LRT
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More FDA Info for this Product Code
Date Received
12/23/1996
Decision Date
09/19/1997
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
Y
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