FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
K Number: K202112
·
Decision Feb 21, 2021
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
7
Applicant Total
3
Review Days
206
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Basic Information
- Device Name
- Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
- K Number
- K202112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4685
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Storz Medical AG
- Date Received
- July 30, 2020
- Decision Date
- February 21, 2021
- Product Code
- PZL
- 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 |
|---|---|---|---|
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | FDA class 2 | General, Plastic Surgery |
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