FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN)
K Number: K862576
·
Decision Jul 15, 1986
Classifications
1
FEI Numbers
398
Registration Numbers
398
Same Product Code
22
Applicant Total
2
Review Days
8
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Basic Information
- Device Name
- PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN)
- K Number
- K862576
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Professional Services For Surgeons, Ltd.
- Date Received
- July 7, 1986
- Decision Date
- July 15, 1986
- Product Code
- FTY
- 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 |
|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Professional Services For Surgeons, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K860912 | PS2 BRAND MAMMAPLASTY | Mar 24, 1986 | Substantially Equivalent |