PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
FDA 510(k) clearance K221860 · decided 2023-09-15
Clearance details
- K-number
- K221860
- Device name
- PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
- Applicant
- Poonglim Pharmatech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-27
- Decision date
- 2023-09-15
- Days to decision
- 445 days
- Clearance type
- Traditional
- Product code
- QNQ
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Gunsan, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.