INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
FDA 510(k) clearance K092782 · decided 2009-12-07
Clearance details
- K-number
- K092782
- Device name
- INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
- Applicant
- Carmel Pharma Ab.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-10
- Decision date
- 2009-12-07
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Molndal, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.