510(k) K891247
- Device
- BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC
- Applicant
- SIEMENS HEARING INSTRUMENTS, INC.
- 510(k) number
- K891247
- Product code
- ESF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-03-29
- Date received
- 1989-03-08
- 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#
- Contact
- L BRANDERBIT
- Address
- 10 Corporate Pl. S. Corporate Park 287 Piscataway NJ US 08854 08854
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ESF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K813224 | CERAVITAL CERAMIC EAR CANAL WALL PROSTH | Xomed, Inc. | 1982-04-21 |
Legacy Summary#
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FDA Review#
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