510(k) K813224
K813224 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "CERAVITAL CERAMIC EAR CANAL WALL PROSTH". The FDA issued a decision of Substantially Equivalent on April 21, 1982. The device falls under product code ESF (Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent), a Class II device regulated under 21 CFR 878.3500. Xomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1982
- Date Received
- November 9, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
- Device Class
- Class II
- Regulation Number
- 878.3500
- Review Panel
- SU
- Submission Type