510(k) K150594
K150594 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorprated for the device "Biodesign Otologic Repair Graft". The FDA issued a decision of Substantially Equivalent on September 16, 2015. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Cook Biotech Incorprated has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2015
- Date Received
- March 9, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Device Class
- Class II
- Regulation Number
- 874.3620
- Review Panel
- EN
- Submission Type