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FDA 510(k)

DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP

K-Number: K920697 · 1992-09-21

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

Device Summary

DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP 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 K920697. The device is classified under product code FJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP?

DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP 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 K920697.

When did DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP receive FDA 510(k) clearance?

DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP received FDA 510(k) clearance on 1992-09-21, under 510(k) number K920697.

Who is the listed applicant for DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP?

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 48-3029-7 CLAMP?

The FDA product code for DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP is FJH.

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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-RK920029DEXTROLYTE II CAPD TRNSFER SET

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Related Devices (Code: FJH)

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.

K861646BIO-CARB D16000, D16001, AND D17000Societe D' Analyses Bio-Pharmaceutiques,Inc.K852764IDECAP DIALYZERTrans-National Trade Development Corp.K822395CF 1211 CAPILLARY FLOW DIALYZER CODETravenol Laboratories, S.A.

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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