510(k) K041984
K041984 is an FDA 510(k) premarket notification submitted by Best Sanitizers, Inc. for the device "ACECIDE HIGH-LEVEL DISINFECTANT AND STERILANT". The FDA issued a decision of Substantially Equivalent on May 11, 2005. 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
- May 11, 2005
- Date Received
- July 23, 2004
- 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