FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TENCKHOFF PERITONEAL TUBING ADAPT.
K Number: K771428
·
Decision Oct 18, 1977
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
164
Review Days
78
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Basic Information
- Device Name
- TENCKHOFF PERITONEAL TUBING ADAPT.
- K Number
- K771428
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- August 1, 1977
- Decision Date
- October 18, 1977
- Product Code
- FKY
- 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 |
|---|---|---|---|
| FKY | Connector, Tubing, Dialysate | FDA class 2 | Gastroenterology, Urology |
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