ACCU-CHEK ULTRAFLEX INFUSION SET
FDA 510(k) clearance K070189 · decided 2007-02-21
Clearance details
- K-number
- K070189
- Device name
- ACCU-CHEK ULTRAFLEX INFUSION SET
- Applicant
- Disetronic Medical Systems AG
- Decision
- Substantially Equivalent
- Date received
- 2007-01-22
- Decision date
- 2007-02-21
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.