FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Jeesung Safety Syringe and Single Use Needles
K Number: K212518
·
Decision Aug 18, 2022
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
3
Review Days
373
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Basic Information
- Device Name
- Jeesung Safety Syringe and Single Use Needles
- K Number
- K212518
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jeesung Medical Co., Ltd.
- Date Received
- August 10, 2021
- Decision Date
- August 18, 2022
- 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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