FDA 510(k) Application Details - K070627

Device Classification Name Sterilant, Medical Devices

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510(K) Number K070627
Device Name Sterilant, Medical Devices
Applicant CIDEN TECHNOLOGIES LLC
540 COLLEGE ST.
BELLAIRE, TX 77401-5010 US
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Contact LISA S JONES
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Regulation Number 880.6885

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Classification Product Code MED
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Date Received 03/06/2007
Decision Date 08/02/2007
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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