FDA 510(k) Application Details - K130172

Device Classification Name Sterilizer, Steam

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510(K) Number K130172
Device Name Sterilizer, Steam
Applicant BELIMED, INC.
2284 Clements Ferry Road
Charleston, SC 29492 US
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Contact JAY UPCHURCH
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Regulation Number 880.6880

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Classification Product Code FLE
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Date Received 01/24/2013
Decision Date 09/23/2013
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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