FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Kopac Sterile Needle
K Number: K172483
·
Decision Jun 21, 2018
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
309
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Basic Information
- Device Name
- Kopac Sterile Needle
- K Number
- K172483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Poonglim Pharmatech, Inc.
- Date Received
- August 16, 2017
- Decision Date
- June 21, 2018
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Poonglim Pharmatech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | May 29, 2024 | Substantially Equivalent |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Sep 15, 2023 | Substantially Equivalent |
| K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Feb 16, 2021 | Substantially Equivalent |
| K210444 | EZ-Injec LDV Sterile Safety Needle | Feb 16, 2021 | Substantially Equivalent |
| K192222 | EZ-Inject Single use Needle | May 12, 2020 | Substantially Equivalent |