FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISCOUS FLUID SYSTEM
K Number: K963434
·
Decision Nov 25, 1996
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
18
Applicant Total
3
Review Days
87
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Basic Information
- Device Name
- VISCOUS FLUID SYSTEM
- K Number
- K963434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Escalon Trek Medical
- Date Received
- August 30, 1996
- Decision Date
- November 25, 1996
- Product Code
- MRH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | FDA class 2 | General Hospital |
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