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FDA 510(k)

DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9

K-Number: K920693 · 1992-09-21

ApplicantNational Medical Care, Medical Products Div., Inc.
Decision Date1992-09-21
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 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 1992-09-21 under 510(k) number K920693. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9?

DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 is a medical device that received FDA 510(k) clearance on 1992-09-21. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K920693.

When did DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 receive FDA 510(k) clearance?

DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 received FDA 510(k) clearance on 1992-09-21, under 510(k) number K920693.

Who is the listed applicant for DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9?

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 PERITONEAL DIALYSIS 48-3028-9?

The FDA product code for DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 is FJG.

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Other records listing National Medical Care, Medical Products Div., Inc. as applicant

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Related Devices (Code: FJG)

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.

K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, Inc.K901368HEMOSPAL KITS A1, A2D, AO, & A1DGambro-Hospal, Inc.K902203TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, Inc.K862840GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NGambro, Inc.

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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