FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
K Number: K023688
·
Decision Jan 30, 2003
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
4
Applicant Total
32
Review Days
90
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Basic Information
- Device Name
- LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
- K Number
- K023688
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- LeMaitre Vascular, Inc.
- Date Received
- November 1, 2002
- Decision Date
- January 30, 2003
- Product Code
- GAF
- 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 |
|---|---|---|---|
| GAF | Spatula, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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