MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
FDA 510(k) clearance K912344 · decided 1991-10-11
Clearance details
- K-number
- K912344
- Device name
- MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
- Applicant
- Dacomed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-28
- Decision date
- 1991-10-11
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- FAE
- Device class
- 2
- Regulation number
- 876.3630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.