FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FAR-EAST SHOE COVERS
K Number: K971191
·
Decision Jul 10, 1997
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
35
Applicant Total
3
Review Days
101
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Basic Information
- Device Name
- FAR-EAST SHOE COVERS
- K Number
- K971191
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Far East Science & Technology Development Co., Ltd.
- Date Received
- March 31, 1997
- Decision Date
- July 10, 1997
- Product Code
- FXP
- 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 |
|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FXP), ordered by most recent decision date.
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