FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FTS-100 FLUID TRANSFER SYSTEM
K Number: K902835
·
Decision Aug 10, 1990
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
2
Review Days
43
Basic Information
- Device Name
- FTS-100 FLUID TRANSFER SYSTEM
- K Number
- K902835
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- RICHARD JAMES, INC.
- Date Received
- June 28, 1990
- Decision Date
- August 10, 1990
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by RICHARD JAMES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K880855 | PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG | Apr 1, 1988 | Substantially Equivalent |