510(k) K813224
- Device
- CERAVITAL CERAMIC EAR CANAL WALL PROSTH
- Applicant
- XOMED, INC.
- 510(k) number
- K813224
- Product code
- ESF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-04-21
- Date received
- 1981-11-09
- Regulation
- 878.3500
- Classification name
- Polymer, Composite Synthetic Ptfe With Carbon-fiber, Ent
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 1318 Lonedell Rd. Arnold MO US 63010 63010
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ESF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891247 | BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC | Siemens Hearing Instruments, Inc. | 1989-03-29 |
Legacy Summary#
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FDA Review#
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