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FDA 510(k)

DISPOSABLE DIALYZERS, SD-ID, SD-2D

K-Number: K790308 · 1979-05-01

ApplicantBentley Laboratories, Inc.
Decision Date1979-05-01
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE DIALYZERS, SD-ID, SD-2D is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1979-05-01 under 510(k) number K790308. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE DIALYZERS, SD-ID, SD-2D?

DISPOSABLE DIALYZERS, SD-ID, SD-2D is a medical device that received FDA 510(k) clearance on 1979-05-01. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K790308.

When did DISPOSABLE DIALYZERS, SD-ID, SD-2D receive FDA 510(k) clearance?

DISPOSABLE DIALYZERS, SD-ID, SD-2D received FDA 510(k) clearance on 1979-05-01, under 510(k) number K790308.

Who is the listed applicant for DISPOSABLE DIALYZERS, SD-ID, SD-2D?

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

What is the FDA product code for DISPOSABLE DIALYZERS, SD-ID, SD-2D?

The FDA product code for DISPOSABLE DIALYZERS, SD-ID, SD-2D is FJI.

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Other records listing Bentley Laboratories, Inc. as applicant

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Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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