DANA DIABECARE IIS
FDA 510(k) clearance K063126 · decided 2007-02-02
Clearance details
- K-number
- K063126
- Device name
- DANA DIABECARE IIS
- Applicant
- Sooil Development Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-13
- Decision date
- 2007-02-02
- Days to decision
- 112 days
- Clearance type
- Special
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.