FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TISSUE MARKER
K Number: K113202
·
Decision Feb 28, 2012
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
109
Applicant Total
5
Review Days
120
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Basic Information
- Device Name
- TISSUE MARKER
- K Number
- K113202
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Focal Therapeutics
- Date Received
- October 31, 2011
- Decision Date
- February 28, 2012
- Product Code
- NEU
- 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 |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | FDA class 2 | General, Plastic Surgery |
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