FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CanGaroo RM Antibacterial Envelope
K Number: K233991
·
Decision Jun 14, 2024
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
1
Review Days
179
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Basic Information
- Device Name
- CanGaroo RM Antibacterial Envelope
- K Number
- K233991
- 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
- Elutia, Inc.
- Date Received
- December 18, 2023
- Decision Date
- June 14, 2024
- 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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