FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
YUE PFONG SAFETY SYRINGE (3ML)
K Number: K040105
·
Decision Apr 7, 2004
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
163
Applicant Total
1
Review Days
78
Basic Information
- Device Name
- YUE PFONG SAFETY SYRINGE (3ML)
- K Number
- K040105
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- YUE PFONG INTERNATIONAL INDUSTRIAL CO., LTD.
- Date Received
- January 20, 2004
- Decision Date
- April 7, 2004
- 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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