FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
FEELject LDV (Low dead volume) syringe
K Number: K213010
·
Decision May 31, 2023
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
11
Applicant Total
4
Review Days
618
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Basic Information
- Device Name
- FEELject LDV (Low dead volume) syringe
- K Number
- K213010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Feeltech Co., Ltd.
- Date Received
- September 20, 2021
- Decision Date
- May 31, 2023
- Product Code
- QNQ
- 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 |
|---|---|---|---|
| QNQ | Low Dead Space Piston Syringe | FDA class 2 | General Hospital |
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