FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
K Number: K080877
·
Decision Oct 21, 2008
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
3
Review Days
204
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Basic Information
- Device Name
- 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
- K Number
- K080877
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unilife Medical Solutions Limited
- Date Received
- March 31, 2008
- Decision Date
- October 21, 2008
- Product Code
- MEG
- 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 |
|---|---|---|---|
| MEG | Syringe, Antistick | FDA class 2 | General Hospital |
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