FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING
K Number: K961177
·
Decision Apr 15, 1996
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
63
Applicant Total
2
Review Days
21
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Basic Information
- Device Name
- CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING
- K Number
- K961177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5780
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Carolina Narrow Fabric Co.
- Date Received
- March 25, 1996
- Decision Date
- April 15, 1996
- Product Code
- DWL
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | FDA class 2 | General Hospital |
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Other Clearances by Carolina Narrow Fabric Co.
| K Number | Device Name | ||
|---|---|---|---|
| K960931 | CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING | May 23, 1996 | Substantially Equivalent |