FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
K Number: K022317
·
Decision Aug 2, 2002
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
83
Applicant Total
4
Review Days
16
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Basic Information
- Device Name
- DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
- K Number
- K022317
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sooil Development Co., Ltd.
- Date Received
- July 17, 2002
- Decision Date
- August 2, 2002
- Product Code
- LZG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZG | Pump, Infusion, Insulin | FDA class 2 | General Hospital |
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