510(k) K191696
- Device
- Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
- Applicant
- Cook Biotech Incorporated
- 510(k) number
- K191696
- Product code
- OXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-12-27
- Date received
- 2019-06-25
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Collagen, Fistula
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Perry W. Guinn
- Address
- 1425 Innovation Pl. West Lafayette IN US 47906 47906
FDA Registration Numbers#
- 1835959
- 1000393132
Source Documents#
Legacy Summary#
summary
FDA Review#
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