510(k) K830667
- Device
- SILICONE-SILVER PENILE PROSTHESIS-ESK
- Applicant
- DACOMED CORP.
- 510(k) number
- K830667
- Product code
- FTQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-20
- Date received
- 1983-03-04
- Regulation
- 876.3630
- Classification name
- Prosthesis, Penis, Rigid Rod
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FTQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983015 | VIRILIS PENILE PROSTHESIS | Specialty Surgical Products, Inc. | 1999-02-05 |
Legacy Summary#
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FDA Review#
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