510(k) K970230

SPOROX by Reckitt Benckiser, Inc. — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1997
Date Received
January 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilant, Medical Devices
Device Class
Class II
Regulation Number
880.6885
Review Panel
HO
Submission Type