FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
Ultrasonic Surgical Aspirator System, Model: XD880B
K Number: K212750
·
Decision Sep 27, 2021
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- Ultrasonic Surgical Aspirator System, Model: XD880B
- K Number
- K212750
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smtp Technology Co., Ltd.
- Date Received
- August 30, 2021
- Decision Date
- September 27, 2021
- Product Code
- LFL
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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