FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SORB SYSTEM URS
K Number: K792137
·
Decision Jan 16, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
18
Applicant Total
130
Review Days
86
Basic Information
- Device Name
- SORB SYSTEM URS
- K Number
- K792137
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5600
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- ORGANON TEKNIKA CORP.
- Date Received
- October 22, 1979
- Decision Date
- January 16, 1980
- Product Code
- FKT
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| FKT | System, Dialysate Delivery, Sorbent Regenerated | FDA class 2 | Gastroenterology, Urology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K993421 | BACT/ALERT SN | Dec 14, 1999 | Substantially Equivalent |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | Dec 14, 1999 | Substantially Equivalent |
| K992432 | BACT/ALERT FN | Sep 24, 1999 | Substantially Equivalent |
| K983762 | NUCLISENS CMV PP67 | Sep 15, 1999 | Substantially Equivalent |
| K992401 | BACT/ALERT PF | Sep 3, 1999 | Substantially Equivalent |