FDA 510(k) Application Details - K963353

Device Classification Name Disinfectant, Medical Devices

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510(K) Number K963353
Device Name Disinfectant, Medical Devices
Applicant RECKITT BENCKISER, INC.
ONE PHILIPS PKWY.
MONTVALE, NJ 07645-1575 US
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Contact RUTH TRAGER
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Regulation Number 880.6890

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Classification Product Code LRJ
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Date Received 08/26/1996
Decision Date 10/18/1996
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

FDA Source Information for K963353


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