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510(k) Data Aggregation
K Number
K022068Device Name
TUBING, DIALYSATE (AND CONNECTOR)
Manufacturer
MOLDED PRODUCTS INC.
Date Cleared
2002-09-23
(90 days)
Product Code
FID
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
MOLDED PRODUCTS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MPC-740: The MPC-740 is a Male to Male Dialysate Connection Connector. It may be used to connect the MPC-725 to the Dialysis machine Dialysate Line in order to extend the length of the Dialysate Tubing. May also be used as a recirculation connector; connecting both dialysis machine Dialysate lines together.
MPC-725: The MPC-725 is a Female to Female Dialysate Connection Connector. When connected to the MPC-740 (which has been connected to the dialysis machines' dialysate line) this line may be used to extend the length of the Dialysis Machine Dialysate Line. The MPC-725 may also be used to connect one Dialyzer Port to another Dialyzer Port.
Device Description
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K Number
K010366Device Name
DISPOSABLE STORAGE CAP
Manufacturer
MOLDED PRODUCTS INC.
Date Cleared
2001-11-28
(294 days)
Product Code
FJI
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
MOLDED PRODUCTS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K010712Device Name
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
Manufacturer
MOLDED PRODUCTS INC.
Date Cleared
2001-09-27
(202 days)
Product Code
FID
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
MOLDED PRODUCTS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003712Device Name
MODIFICATION TO MALE TO MALE LUER ADAPTER
Manufacturer
MOLDED PRODUCTS INC.
Date Cleared
2001-05-16
(166 days)
Product Code
KOC
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
MOLDED PRODUCTS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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