MEDE-FLO I.V. EXTENSION SET
FDA 510(k) clearance K912856 · decided 1991-12-17
Clearance details
- K-number
- K912856
- Device name
- MEDE-FLO I.V. EXTENSION SET
- Applicant
- Medevice, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-28
- Decision date
- 1991-12-17
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Canada L4w 4m2, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.