FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Fluid, Hysteroscopy
PMA: N17511
·
Decision Sep 15, 1975
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Fluid, Hysteroscopy
- Trade Name
- HYSKON (32% DEXTRAN 70)
- PMA Number
- N17511
- Device Class
- FDA Class 3
- Product Code
- LTA
- Generic Name
- FLUID, HYSTEROSCOPY
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- September 15, 1975
- Date Received
- July 7, 1975
- Expedited Review
- N
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LTA | Fluid, Hysteroscopy | FDA class 3 | Unknown |