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FDA 510(k)

HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR

K-Number: K990479 · 1999-05-13

ApplicantHygenitek, Inc.
Decision Date1999-05-13
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Hygenitek, Inc.. It received FDA 510(k) clearance on 1999-05-13 under 510(k) number K990479. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR?

HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR is a medical device that received FDA 510(k) clearance on 1999-05-13. The listed applicant is Hygenitek, Inc.. The 510(k) number is K990479.

When did HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR receive FDA 510(k) clearance?

HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR received FDA 510(k) clearance on 1999-05-13, under 510(k) number K990479.

Who is the listed applicant for HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR?

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

What is the FDA product code for HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR?

The FDA product code for HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR is EIA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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