FDA 510(k) Application Details - K932922

Device Classification Name Sterilant, Medical Devices

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510(K) Number K932922
Device Name Sterilant, Medical Devices
Applicant COTTRELL, LTD.
7399 SOUTH TUCSON WAY
ENGLEWOOD, CO US
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Contact JACK SCOVILLE
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Regulation Number 880.6885

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Classification Product Code MED
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Date Received 06/15/1993
Decision Date 07/03/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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