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FDA 510(k)

HORIZON XL

K-Number: K911616 · 1991-07-10

ApplicantMennen Medical, Inc.
Decision Date1991-07-10
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HORIZON XL 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 1991-07-10 under 510(k) number K911616. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZON XL?

HORIZON XL is a medical device that received FDA 510(k) clearance on 1991-07-10. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K911616.

When did HORIZON XL receive FDA 510(k) clearance?

HORIZON XL received FDA 510(k) clearance on 1991-07-10, under 510(k) number K911616.

Who is the listed applicant for HORIZON XL?

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 XL?

The FDA product code for HORIZON XL is DRT.

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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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Related Devices (Code: DRT)

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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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