FDA 510(k) Application Details - K991509

Device Classification Name Disinfectant, Medical Devices

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510(K) Number K991509
Device Name Disinfectant, Medical Devices
Applicant SULTAN CHEMISTS, INC.
85 WEST FOREST AVE.
ENGLEWOOD, NJ 07631 US
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Contact LES HEIMANN
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Regulation Number 880.6890

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Classification Product Code LRJ
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Date Received 04/30/1999
Decision Date 07/14/1999
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

FDA Source Information for K991509


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