FDA 510(k) Application Details - K081094

Device Classification Name Disinfector, Medical Devices

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510(K) Number K081094
Device Name Disinfector, Medical Devices
Applicant OLYMPIC MEDICAL CORP.
5900 FIRST AVE., SOUTH
SEATTLE, WA 98108 US
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Contact STEVE HESLER
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Regulation Number 880.6992

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Classification Product Code MEC
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Date Received 04/17/2008
Decision Date 06/20/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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