FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Kitazato OPU Needles
K Number: K162881
·
Decision Jul 11, 2017
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
13
Review Days
270
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Basic Information
- Device Name
- Kitazato OPU Needles
- K Number
- K162881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6100
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kitazato Corporation
- Date Received
- October 14, 2016
- Decision Date
- July 11, 2017
- Product Code
- MQE
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| MQE | Needle, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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