FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIK-TEMP
K Number: K800666
·
Decision May 8, 1980
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
3
Review Days
43
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
- QUIK-TEMP
- K Number
- K800666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Liquid Crystal Products, Inc.
- Date Received
- March 26, 1980
- Decision Date
- May 8, 1980
- Product Code
- KPP
- 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 |
|---|---|---|---|
| KPP | Peritoneal Dialysate Filter | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPP), ordered by most recent decision date.
TM-CAPD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KPP PERITONEAL DIALYSATE FILTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology