510(k) K962379
K962379 is an FDA 510(k) premarket notification submitted by National Rehab Hospital for the device "SEAGER ELECTROEJACULATOR". The FDA issued a decision of Substantially Equivalent on September 18, 1997. The device falls under product code LNL (Stimulator, Electrical For Sperm Collection), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1997
- Date Received
- June 20, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical For Sperm Collection
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type