FDA 510(k) Application Details - K983869

Device Classification Name Disinfectant, Medical Devices

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510(K) Number K983869
Device Name Disinfectant, Medical Devices
Applicant CALTECH INDUSTRIES, INC.
2420 SCHUETTE DR.
MIDLAND, MI 48642 US
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Contact DONALD A JOHNSON
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Regulation Number 880.6890

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Classification Product Code LRJ
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Date Received 11/02/1998
Decision Date 11/30/1998
Decision SESE - SUBST EQUIV
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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