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FDA 510(k) Application Details - K013280
Device Classification Name
Sterilant, Medical Devices
More FDA Info for this Device
510(K) Number
K013280
Device Name
Sterilant, Medical Devices
Applicant
STERILOX TECHNOLOGIES, INC.
HESTON HALL/CARRIAGE HOUSE
1790 YARDLEY-LANGHORNE ROAD
YARDLEY, PA 19067 US
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Contact
HOWARD MANN
Other 510(k) Applications for this Contact
Regulation Number
880.6885
More FDA Info for this Regulation Number
Classification Product Code
MED
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/02/2001
Decision Date
09/18/2002
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
Y
Expedited Review
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