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FDA 510(k) Application Details - K970230
Device Classification Name
Sterilant, Medical Devices
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.6885
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Classification Product Code
MED
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More FDA Info for this Product Code
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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