FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
INFUSION SYRINGE SET
K Number: K131661
·
Decision Nov 5, 2013
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
3
Review Days
151
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Basic Information
- Device Name
- INFUSION SYRINGE SET
- K Number
- K131661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Medical Manufacturing Co.
- Date Received
- June 7, 2013
- Decision Date
- November 5, 2013
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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