FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPD STAGED CONNECTOR
K Number: K845041
·
Decision Feb 21, 1985
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
15
Applicant Total
883
Review Days
55
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Basic Information
- Device Name
- CAPD STAGED CONNECTOR
- K Number
- K845041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- December 28, 1984
- Decision Date
- February 21, 1985
- Product Code
- FKO
- 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 |
|---|---|---|---|
| FKO | Catheter, Peritoneal Dialysis, Single Use | FDA class 2 | Gastroenterology, Urology |
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