ENFit Disposable Enteral Syringe
FDA 510(k) clearance K203410 · decided 2021-06-28
Clearance details
- K-number
- K203410
- Device name
- ENFit Disposable Enteral Syringe
- Applicant
- Shantou Wealy Medical Instrument Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2020-11-19
- Decision date
- 2021-06-28
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- PNR
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Shantou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.