ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
FDA 510(k) clearance K120872 · decided 2012-04-20
Clearance details
- K-number
- K120872
- Device name
- ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
- Applicant
- Unomedical A/S Infusion Devices
- Decision
- Substantially Equivalent
- Date received
- 2012-03-22
- Decision date
- 2012-04-20
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Osted, DK
- Third-party review
- No
- Expedited review
- No
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