510(k) K010712
- Device
- DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
- Applicant
- MOLDED PRODUCTS INC.
- 510(k) number
- K010712
- Product code
- FID
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-27
- Date received
- 2001-03-09
- Regulation
- 876.5820
- Classification name
- Tubing, Dialysate
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELISE JOHNSTON
- Address
- 601 Durant St. Harlan IA US 51537 51537
FDA Registration Numbers#
- 1424263
- 1932668
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FID #
Legacy Summary#
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FDA Review#
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