510(k) K091210

ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT by Best Sanitizers, Inc. — Product Code MED

K091210 is an FDA 510(k) premarket notification submitted by Best Sanitizers, Inc. for the device "ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT". The FDA issued a decision of Substantially Equivalent on February 5, 2010. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Best Sanitizers, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2010
Date Received
April 24, 2009
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