Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
Cook Biotech Incorporated · Ear, Nose, Throat
Open FDA's page for this record- Third party flag
- N
- City
- West Lafayette
- Advisory committee description
- Ear, Nose, Throat
- Address 1
- 1425 Innovation Pl.
- Statement or summary
- Summary
- Product code
- KHJ
- Zip code
- 47906
- Applicant
- Cook Biotech Incorporated
- Decision date
- 2024-05-24
- Decision code
- SESE
- Country code
- US
- Device name
- Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
- Advisory committee
- EN
- Contact
- Christopher Lotzow
- K number
- K232646
- State
- IN
- Date received
- 2023-08-30
- Review advisory committee
- EN
- Postal code
- 47906
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Medical specialty description
- Ear, Nose, Throat
- Regulation number
- 874.3620
- Device class
- 2
- Registration number
- 3011050570, 3006306415, 3018094310, 1048735, 1531062, 3002806953, 1416980, 1835959, 1057421, 1052728, 3003418325, 3014334038, 3004450973, 3002807315, 3009217531, 3017636737, 1045254, 3013840437, 1000393132, 2135225, 1928237, 3009403363, 9612501
- FEI number
- 3011050570, 3006306415, 3018094310, 1048735, 3002806953, 1416980, 1000113735, 3003495548, 3003418325, 3014334038, 1000022662, 3004450973, 3002807315, 3009217531, 3017636737, 1045254, 3013840437, 1000393132, 3002340648, 3002768455, 1928237, 3009403363, 3003407669