PHASEAL PROTECTOR P14, P21, P28 AND P50
FDA 510(k) clearance K090634 · decided 2009-03-23
Clearance details
- K-number
- K090634
- Device name
- PHASEAL PROTECTOR P14, P21, P28 AND P50
- Applicant
- Carmel Pharma Ab.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-09
- Decision date
- 2009-03-23
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Gothenburg, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.