FDA 510(k) Application Details - K122978

Device Classification Name Sterilizer, Steam

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510(K) Number K122978
Device Name Sterilizer, Steam
Applicant ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT
17319 LAKE BLVD.
SHAFER, MN 55074 US
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Contact ISAAC ERICKSON
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 09/26/2012
Decision Date 05/23/2013
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

FDA Source Information for K122978


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