Biodesign Otologic Repair Graft
FDA 510(k) clearance K161000 · decided 2016-05-11
Clearance details
- K-number
- K161000
- Device name
- Biodesign Otologic Repair Graft
- Applicant
- Cook Biotech Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2016-04-11
- Decision date
- 2016-05-11
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- KHJ
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- 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.