FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ProTEC-USA EZDoff Gown
K Number: K210405
·
Decision Dec 15, 2021
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
8
Applicant Total
1
Review Days
308
Basic Information
- Device Name
- ProTEC-USA EZDoff Gown
- K Number
- K210405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cadillac Products, Inc.
- Date Received
- February 10, 2021
- Decision Date
- December 15, 2021
- Product Code
- QPC
- 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 |
|---|---|---|---|
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | FDA class 2 | General, Plastic Surgery |
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