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FDA 510(k)

DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1

K-Number: K896600 · 1990-03-22

ApplicantNational Medical Care, Medical Products Div., Inc.
Decision Date1990-03-22
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1 is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Care, Medical Products Div., Inc.. It received FDA 510(k) clearance on 1990-03-22 under 510(k) number K896600. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1?

DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1 is a medical device that received FDA 510(k) clearance on 1990-03-22. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K896600.

When did DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1 receive FDA 510(k) clearance?

DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1 received FDA 510(k) clearance on 1990-03-22, under 510(k) number K896600.

Who is the listed applicant for DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1?

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

What is the FDA product code for DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1?

The FDA product code for DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1 is KDJ.

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Other records listing National Medical Care, Medical Products Div., 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.

K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETK941757FORMALIN REUSE CARTK952343FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZERK930843RAPID DISCONNECT Y-SET, CAT. NO. 48-7000K914790HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-RK920697DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP

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Related Devices (Code: KDJ)

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.

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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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