FDA 510(k) Application Details - K102894

Device Classification Name Indicator, Physical/Chemical Sterilization Process

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510(K) Number K102894
Device Name Indicator, Physical/Chemical Sterilization Process
Applicant PROPPER MFG. CO., INC.
36-04 SKILLMAN AVE.
LONG ISLAND CITY, NY 11101 US
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Contact ANDREW SHARAVARA
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Regulation Number 880.2800

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Classification Product Code JOJ
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Date Received 09/30/2010
Decision Date 05/25/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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