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FDA 510(k)

SPIRAFLOW DIALYZERS

K-Number: K772423 · 1978-01-26

ApplicantBentley Laboratories, Inc.
Decision Date1978-01-26
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPIRAFLOW DIALYZERS 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 1978-01-26 under 510(k) number K772423. 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 SPIRAFLOW DIALYZERS?

SPIRAFLOW DIALYZERS is a medical device that received FDA 510(k) clearance on 1978-01-26. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K772423.

When did SPIRAFLOW DIALYZERS receive FDA 510(k) clearance?

SPIRAFLOW DIALYZERS received FDA 510(k) clearance on 1978-01-26, under 510(k) number K772423.

Who is the listed applicant for SPIRAFLOW DIALYZERS?

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 SPIRAFLOW DIALYZERS?

The FDA product code for SPIRAFLOW DIALYZERS 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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