70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
FDA 510(k) clearance K091185 · decided 2009-07-24
Clearance details
- K-number
- K091185
- Device name
- 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
- Applicant
- Hsiner Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-23
- Decision date
- 2009-07-24
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.