FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ControlRad Sterile Cover
K Number: K200238
·
Decision Apr 26, 2020
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
449
Applicant Total
3
Review Days
86
Basic Information
- Device Name
- ControlRad Sterile Cover
- K Number
- K200238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ControlRad, Inc
- Date Received
- January 31, 2020
- Decision Date
- April 26, 2020
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical | FDA class 2 | General, Plastic Surgery |
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