FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PMT-OPTICA LINE
K Number: K831118
·
Decision Jan 25, 1984
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
3
Review Days
295
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Basic Information
- Device Name
- PMT-OPTICA LINE
- K Number
- K831118
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Pmt, Inc.
- Date Received
- April 5, 1983
- Decision Date
- January 25, 1984
- Product Code
- KDC
- 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | FDA class 1 | General, Plastic Surgery |
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