510(k) K851719
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 1985
- Date Received
- April 25, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Vas Deferens
- Device Class
- Class III
- Regulation Number
- Review Panel
- GU
- Submission Type