510(k) K041360
K041360 is an FDA 510(k) premarket notification submitted by Healthpoint, Ltd. for the device "ALDAHOL III HIGH-LEVEL DISINFECTANT". The FDA issued a decision of Substantially Equivalent on May 5, 2005. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Healthpoint, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2005
- Date Received
- May 21, 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