FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
K Number: K091142
·
Decision Aug 31, 2009
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
3
Review Days
133
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Basic Information
- Device Name
- TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
- K Number
- K091142
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rti Biologics, Inc.
- Date Received
- April 20, 2009
- Decision Date
- August 31, 2009
- 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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