NIPRO SUREFUSER AMBULATORY INFUSION PUMP
FDA 510(k) clearance K051828 · decided 2005-12-15
Clearance details
- K-number
- K051828
- Device name
- NIPRO SUREFUSER AMBULATORY INFUSION PUMP
- Applicant
- Nipro Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-07-06
- Decision date
- 2005-12-15
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- MEB
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lexington, KY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.