FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNO 30
K Number: K190028
·
Decision Jan 15, 2020
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
2
Review Days
373
Basic Information
- Device Name
- UNO 30
- K Number
- K190028
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genadyne Biotechnologies
- Date Received
- January 7, 2019
- Decision Date
- January 15, 2020
- Product Code
- OMP
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Genadyne Biotechnologies
| K Number | Device Name | ||
|---|---|---|---|
| K182722 | XLR8 Abdominal Wound Dressing Kit | Sep 27, 2019 | Substantially Equivalent |