FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Biodesign Enterocutaneous Fistula Plug
K Number: K150668
·
Decision Dec 9, 2015
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
4
Review Days
268
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Basic Information
- Device Name
- Biodesign Enterocutaneous Fistula Plug
- K Number
- K150668
- 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
- Cook Biotech Incorprated
- Date Received
- March 16, 2015
- Decision Date
- December 9, 2015
- 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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