FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SEAGER ELECTROEJACULATOR
K Number: K962379
·
Decision Sep 18, 1997
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
1
Review Days
455
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SEAGER ELECTROEJACULATOR
- K Number
- K962379
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- National Rehab Hospital
- Date Received
- June 20, 1996
- Decision Date
- September 18, 1997
- Product Code
- LNL
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNL | Stimulator, Electrical For Sperm Collection | FDA unclassified | Unknown |