FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Safety Blood Collection Device for Single Use
K Number: K170276
·
Decision Dec 11, 2017
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
5
Review Days
315
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Basic Information
- Device Name
- Safety Blood Collection Device for Single Use
- K Number
- K170276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gemtier Medical (Shanghai), Inc.
- Date Received
- January 30, 2017
- Decision Date
- December 11, 2017
- Product Code
- FMI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Gemtier Medical (Shanghai), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K212652 | Sterile Syringe with Fixed Safety Needle for Single Use | Mar 2, 2022 | Substantially Equivalent |
| K202493 | Medical Face Mask | Feb 4, 2021 | Substantially Equivalent |
| K202331 | Medical Face Mask | Feb 2, 2021 | Substantially Equivalent |
| K192679 | Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use | Apr 10, 2020 | Substantially Equivalent |