510(k) K983015
- Device
- VIRILIS PENILE PROSTHESIS
- Applicant
- SPECIALTY SURGICAL PRODUCTS, INC.
- 510(k) number
- K983015
- Product code
- FTQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-02-05
- Date received
- 1998-08-28
- Regulation
- 876.3630
- Classification name
- Prosthesis, Penis, Rigid Rod
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- T.JAN VARNER
- Address
- 302 N. First St. Hamilton MT US 59840 59840
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FTQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K830667 | SILICONE-SILVER PENILE PROSTHESIS-ESK | Dacomed Corp. | 1983-10-20 |
Legacy Summary#
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FDA Review#
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