DISPOSABLE INFUSION SET
FDA 510(k) clearance K131646 · decided 2013-11-26
Clearance details
- K-number
- K131646
- Device name
- DISPOSABLE INFUSION SET
- Applicant
- Shanghai Jinta Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-06-05
- Decision date
- 2013-11-26
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Fengjing Town, Jinshan District, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.