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FDA 510(k)

CF 1211 CAPILLARY FLOW DIALYZER CODE

K-Number: K822395 · 1982-08-12

ApplicantTravenol Laboratories, S.A.
Decision Date1982-08-12
Product CodeFJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CF 1211 CAPILLARY FLOW DIALYZER CODE is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1982-08-12 under 510(k) number K822395. 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 CF 1211 CAPILLARY FLOW DIALYZER CODE?

CF 1211 CAPILLARY FLOW DIALYZER CODE is a medical device that received FDA 510(k) clearance on 1982-08-12. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K822395.

When did CF 1211 CAPILLARY FLOW DIALYZER CODE receive FDA 510(k) clearance?

CF 1211 CAPILLARY FLOW DIALYZER CODE received FDA 510(k) clearance on 1982-08-12, under 510(k) number K822395.

Who is the listed applicant for CF 1211 CAPILLARY FLOW DIALYZER CODE?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CF 1211 CAPILLARY FLOW DIALYZER CODE?

The FDA product code for CF 1211 CAPILLARY FLOW DIALYZER CODE is FJH.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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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.

K920697DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMPNational Medical Care, Medical Products Div., Inc.K861646BIO-CARB D16000, D16001, AND D17000Societe D' Analyses Bio-Pharmaceutiques,Inc.K852764IDECAP DIALYZERTrans-National Trade Development 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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