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FDA 510(k)

HORIZON 9000 WS

K-Number: K940415 · 1995-01-06

ApplicantMennen Medical, Inc.
Decision Date1995-01-06
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HORIZON 9000 WS is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical, Inc.. It received FDA 510(k) clearance on 1995-01-06 under 510(k) number K940415. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZON 9000 WS?

HORIZON 9000 WS is a medical device that received FDA 510(k) clearance on 1995-01-06. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K940415.

When did HORIZON 9000 WS receive FDA 510(k) clearance?

HORIZON 9000 WS received FDA 510(k) clearance on 1995-01-06, under 510(k) number K940415.

Who is the listed applicant for HORIZON 9000 WS?

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

What is the FDA product code for HORIZON 9000 WS?

The FDA product code for HORIZON 9000 WS is DXG.

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Other records listing Mennen Medical, Inc. 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.

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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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