Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
FDA 510(k) clearance K192679 · decided 2020-04-10
Clearance details
- K-number
- K192679
- Device name
- Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
- Applicant
- Gemtier Medical (Shanghai), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-26
- Decision date
- 2020-04-10
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shanghai, CN
- 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.