510(k) K133011
- Device
- DIAPHRAGMATIC HERNIA GRAFT
- Applicant
- COOK BIOTECH, INC.
- 510(k) number
- K133011
- Product code
- OWV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-06-20
- Date received
- 2013-09-25
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Collagen, Diaphragmatic Hernia
- 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
- MARY A FADERAN PH.D., RAC
- Address
- 1425 Innovation Pl. West Lafayette IN US 47906 47906
FDA Registration Numbers#
- 2024024
- 1000393132
- 3005920706
- 3005636544
- 3009504230
- 1835959
- 3009882464
- 3003418325
- 3012102437
- 1213643
- 9680579
Source Documents#
Legacy Summary#
summary
FDA Review#
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