EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
FDA 510(k) clearance K091890 · decided 2010-03-24
Clearance details
- K-number
- K091890
- Device name
- EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
- Applicant
- Healthpoint, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-23
- Decision date
- 2010-03-24
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- MED
- Device class
- 2
- Regulation number
- 880.6885
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.