510(k) K990703

SPOROX II STERILIZING & DISINFECTING SOLUTION by Reckitt Benckiser, Inc. — Product Code MED

K990703 is an FDA 510(k) premarket notification submitted by Reckitt Benckiser, Inc. for the device "SPOROX II STERILIZING & DISINFECTING SOLUTION". The FDA issued a decision of Substantially Equivalent on March 30, 1999. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Reckitt Benckiser, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1999
Date Received
March 4, 1999
Clearance Type
Special
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