FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCU-LINE SURGICAL MARKER
K Number: K830298
·
Decision Jun 2, 1983
Classifications
1
FEI Numbers
183
Registration Numbers
184
Same Product Code
22
Applicant Total
4
Review Days
125
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Basic Information
- Device Name
- ACCU-LINE SURGICAL MARKER
- K Number
- K830298
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4660
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Accu-Line
- Date Received
- January 28, 1983
- Decision Date
- June 2, 1983
- Product Code
- FZZ
- 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 |
|---|---|---|---|
| FZZ | Marker, Skin | FDA class 1 | General, Plastic Surgery |
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