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FDA 510(k)

ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)

K-Number: K890997 · 1989-03-28

ApplicantAtlantic Wholesale, Inc.
Decision Date1989-03-28
Product CodeKEA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Wholesale, Inc.. It received FDA 510(k) clearance on 1989-03-28 under 510(k) number K890997. The device is classified under product code KEA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)?

ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) is a medical device that received FDA 510(k) clearance on 1989-03-28. The listed applicant is Atlantic Wholesale, Inc.. The 510(k) number is K890997.

When did ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) receive FDA 510(k) clearance?

ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) received FDA 510(k) clearance on 1989-03-28, under 510(k) number K890997.

Who is the listed applicant for ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)?

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

What is the FDA product code for ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)?

The FDA product code for ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) is KEA.

Related Clinical Trials

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Related Devices (Code: KEA)

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.

K844948SYVA SOLID PHASE COLUMNSSyva Co.K842028CM-TRISACRYL M DEAE-TRISACRYL MLkb Instruments, Inc.K833320AMBERLITE CG50 RESIN, 100-200 MESHBiosan Laboratories, Inc.K833319BIO-REX 70 RESIN 100-200 MESH PH6.2Biosan Laboratories, Inc.K831027EXTRELUT QE EXTRACTION COLUMNSEmd Chemicals, Inc.K830918I.E.C COLUMNBerwick Medical Products, 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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