510(k) K771428
- Device
- TENCKHOFF PERITONEAL TUBING ADAPT.
- Applicant
- QUINTON, INC.
- 510(k) number
- K771428
- Product code
- FKY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-10-18
- Date received
- 1977-08-01
- 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
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K830002 | CAPD COLOR-GUARD SYSTEM PREPKIT | Abbott Laboratories | 1983-03-11 |
Legacy Summary#
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FDA Review#
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