FDA 510(k) Application Details - K970230

Device Classification Name Sterilant, Medical Devices

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510(K) Number K970230
Device Name Sterilant, Medical Devices
Applicant RECKITT BENCKISER, INC.
ONE PHILIPS PKWY.
MONTVALE, NJ 07645-1575 US
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Contact EILEEN J MOYER
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Regulation Number 880.6885

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Classification Product Code MED
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Date Received 01/21/1997
Decision Date 10/29/1997
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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