FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Skypro, Surgical Gown 6021
K Number: K230707
·
Decision Oct 12, 2023
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
3
Review Days
212
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Basic Information
- Device Name
- Skypro, Surgical Gown 6021
- K Number
- K230707
- 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
- Skypro Medical Supplies Company
- Date Received
- March 14, 2023
- Decision Date
- October 12, 2023
- Product Code
- FYA
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
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