FDA 510(k) Application Details - K962739

Device Classification Name Disinfectant, Medical Devices

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510(K) Number K962739
Device Name Disinfectant, Medical Devices
Applicant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
P.O. BOX 4000
PRINCETON, NJ 08540 US
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Contact MICHAEL G SARLI
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Regulation Number 880.6890

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Classification Product Code LRJ
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Date Received 07/15/1996
Decision Date 10/07/1996
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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