FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VILLAN (VIDEO LIFT LINK ANALYSIS)
K Number: K910712
·
Decision May 21, 1991
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
7
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- VILLAN (VIDEO LIFT LINK ANALYSIS)
- K Number
- K910712
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Physio Systems, Inc.
- Date Received
- February 20, 1991
- Decision Date
- May 21, 1991
- Product Code
- LXI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LXI | Guide, Drill, Ligament | FDA class 1 | General, Plastic Surgery |
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