Ceravital Ceramic Ear Canal Wall Prosth
FDA 510(k) K813224 · Xomed, Inc.
510(k) numberK813224
Submission
- Device name
- Ceravital Ceramic Ear Canal Wall Prosth
- Applicant
- Xomed, Inc.
Arnold, MO, US - Received
- November 9, 1981
- Decision date
- April 21, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ESF – Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3500
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code ESF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891247 | Behind-The-Ear Hearing Aid Model 404 Pp-PcESF · Traditional | Siemens Hearing Instruments, Inc. | 03/29/1989SE |
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| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
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| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Ceravital Ceramic Ear Canal Wall Prosth cleared by the FDA?
Ceravital Ceramic Ear Canal Wall Prosth (K813224) received a 510(k) decision of Substantially Equivalent on April 21, 1982, 163 days after the submission was received.
What is the product code of K813224?
The FDA product code is ESF – Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent, a Class II (moderate risk) device regulated under 21 CFR 878.3500.