Disposable sterile needle retractable safety syringe
FDA 510(k) clearance K141349 · decided 2015-04-10
Clearance details
- K-number
- K141349
- Device name
- Disposable sterile needle retractable safety syringe
- Applicant
- Guangdong Haiou Medical Apparatus Stock Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-05-22
- Decision date
- 2015-04-10
- Days to decision
- 323 days
- Clearance type
- Traditional
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Puning City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.