NEOMED SINGLE LUMEN UMBILICAL CATHETER
FDA 510(k) clearance K073596 · decided 2008-02-22
Clearance details
- K-number
- K073596
- Device name
- NEOMED SINGLE LUMEN UMBILICAL CATHETER
- Applicant
- Neomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-21
- Decision date
- 2008-02-22
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- FOS
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Swanee, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.