Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
FDA 510(k) clearance K191696 · decided 2019-12-27
Clearance details
- K-number
- K191696
- Device name
- Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
- Applicant
- Cook Biotech Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2019-06-25
- Decision date
- 2019-12-27
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- OXN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- West Lafayette, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.