FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL APPAREL SHOE COVERS
K Number: K831952
·
Decision Jul 12, 1983
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
2
Applicant Total
4
Review Days
27
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Basic Information
- Device Name
- SURGICAL APPAREL SHOE COVERS
- K Number
- K831952
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sudreca Surgical Dressings, Inc.
- Date Received
- June 15, 1983
- Decision Date
- July 12, 1983
- Product Code
- BWP
- 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 |
|---|---|---|---|
| BWP | Shoe And Shoe Cover, Conductive | FDA class 1 | General, Plastic Surgery |
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