FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMAVAC® 100 Sustained Vacuum System
K Number: K231063
·
Decision May 12, 2023
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- SOMAVAC® 100 Sustained Vacuum System
- K Number
- K231063
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Somavac Medical Solutions, Inc.
- Date Received
- April 14, 2023
- Decision Date
- May 12, 2023
- Product Code
- BTA
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
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