FDA 510(k) Application Details - K013228

Device Classification Name Indicator, Physical/Chemical Sterilization Process

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510(K) Number K013228
Device Name Indicator, Physical/Chemical Sterilization Process
Applicant MINNESOTA MINING AND MFG. CO.
5353 WAYZATA BLVD.
SUITE 505
MINNEAPOLIS, MN 55416 US
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Contact TIERNEY NORSTED
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Regulation Number 880.2800

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Classification Product Code JOJ
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Date Received 09/27/2001
Decision Date 01/18/2002
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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