FDA 510(k) Application Details - K981023

Device Classification Name Disinfectant, Medical Devices

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510(K) Number K981023
Device Name Disinfectant, Medical Devices
Applicant METREX RESEARCH CORP.
1717 W COLLINS AVE.
ORANGE, CA 92667 US
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Contact WENDY A URTEL
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Regulation Number 880.6890

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Classification Product Code LRJ
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Date Received 03/19/1998
Decision Date 04/30/1998
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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