FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Miromatrix Biological Mesh RS
K Number: K150341
·
Decision May 12, 2015
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
3
Applicant Total
5
Review Days
90
Basic Information
- Device Name
- Miromatrix Biological Mesh RS
- K Number
- K150341
- 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
- MIROMATRIX MEDICAL INC.
- Date Received
- February 11, 2015
- Decision Date
- May 12, 2015
- Product Code
- OXH
- 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 |
|---|---|---|---|
| OXH | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | FDA class 2 | General, Plastic Surgery |
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