ALPHA MICRON 20/40 MICROAGGREGATE FILTER
FDA 510(k) clearance K970225 · decided 1997-02-14
Clearance details
- K-number
- K970225
- Device name
- ALPHA MICRON 20/40 MICROAGGREGATE FILTER
- Applicant
- Alpha Therapeutic Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-17
- Decision date
- 1997-02-14
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- CAK
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.