FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOFORM RECONSTRUCTIVE TEMPLATE
K Number: K130547
·
Decision May 31, 2013
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
1
Review Days
88
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Basic Information
- Device Name
- ENDOFORM RECONSTRUCTIVE TEMPLATE
- K Number
- K130547
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mesynthe, Ltd.
- Date Received
- March 4, 2013
- Decision Date
- May 31, 2013
- Product Code
- FTM
- 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
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