Biodesign Otologic Repair Graft— 510(k) K161000
Substantially EquivalentCook Biotech Incorporated
FDA 510(k) clearance K161000 for Biodesign Otologic Repair Graft, Substantially Equivalent on 2016-05-11. Applicant: Cook Biotech Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Biotech Incorporated
- Product code
- Code KHJ
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Lafayette, IN, US
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