510(k) K830002
- Device
- Capd Color-guard System Prepkit
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K830002
- Product code
- FKY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-11
- Date received
- 1983-01-03
- Regulation
- 876.5820
- Classification name
- Connector, Tubing, Dialysate
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FKY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991003 | PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI | Dayspring Medical, Inc. | 1999-06-09 |
| K862722 | TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE | Mercury Enterprises, Inc. | 1986-08-11 |
| K771428 | TENCKHOFF PERITONEAL TUBING ADAPT. | Quinton, Inc. | 1977-10-18 |