FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
K Number: K080158
·
Decision May 2, 2008
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
7
Applicant Total
1
Review Days
100
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Basic Information
- Device Name
- LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
- K Number
- K080158
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lb Medical LLC
- Date Received
- January 23, 2008
- Decision Date
- May 2, 2008
- Product Code
- FZW
- 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 |
|---|---|---|---|
| FZW | Expander, Surgical, Skin Graft | FDA class 1 | General, Plastic Surgery |
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