The following data is part of a premarket notification filed by National Rehab Hospital with the FDA for Seager Electroejaculator.
Device ID | K962379 |
510k Number | K962379 |
Device Name: | SEAGER ELECTROEJACULATOR |
Classification | Stimulator, Electrical For Sperm Collection |
Applicant | NATIONAL REHAB HOSPITAL 102 IRVING STREET, N.W. Washington, DC 20010 -2949 |
Contact | S.w.j. Seager |
Correspondent | S.w.j. Seager NATIONAL REHAB HOSPITAL 102 IRVING STREET, N.W. Washington, DC 20010 -2949 |
Product Code | LNL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-20 |
Decision Date | 1997-09-18 |
Summary: | summary |