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FDA 510(k)

DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES

K-Number: K010712 · 2001-09-27

ApplicantMolded Products, Inc.
Decision Date2001-09-27
Product CodeFID
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES is the device name listed in this FDA 510(k) record. The listed applicant is Molded Products, Inc.. It received FDA 510(k) clearance on 2001-09-27 under 510(k) number K010712. The device is classified under product code FID. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES?

DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES is a medical device that received FDA 510(k) clearance on 2001-09-27. The listed applicant is Molded Products, Inc.. The 510(k) number is K010712.

When did DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES receive FDA 510(k) clearance?

DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES received FDA 510(k) clearance on 2001-09-27, under 510(k) number K010712.

Who is the listed applicant for DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES?

The FDA 510(k) record lists Molded Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES?

The FDA product code for DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES is FID.

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Other records listing Molded Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022068TUBING, DIALYSATE (AND CONNECTOR)K010366DISPOSABLE STORAGE CAPK003712MODIFICATION TO MALE TO MALE LUER ADAPTERK925978MPC-80 TRANSDUCERK925927MPC-1000 INJECTION CAP/PLUGK925930MPC-150 MALE TO MALE LUER ADAPTER

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Related Devices (Code: FID)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022068TUBING, DIALYSATE (AND CONNECTOR)Molded Products, Inc.K770299TYGON M-60/TYGON M-70Norton Performance Plastics Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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