FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPD COLOR-GUARD SYSTEM PREPKIT
K Number: K830002
·
Decision Mar 11, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
883
Review Days
67
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Basic Information
- Device Name
- CAPD COLOR-GUARD SYSTEM PREPKIT
- K Number
- K830002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- January 3, 1983
- Decision Date
- March 11, 1983
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKY), ordered by most recent decision date.
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FDA Class 2
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TENCKHOFF PERITONEAL TUBING ADAPT.
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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