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FDA 510(k)

VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8

K-Number: K092653 · 2009-09-18

ApplicantMedcom GmbH
Decision Date2009-09-18
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 is the device name listed in this FDA 510(k) record. The listed applicant is Medcom GmbH. It received FDA 510(k) clearance on 2009-09-18 under 510(k) number K092653. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8?

VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 is a medical device that received FDA 510(k) clearance on 2009-09-18. The listed applicant is Medcom GmbH. The 510(k) number is K092653.

When did VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 receive FDA 510(k) clearance?

VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 received FDA 510(k) clearance on 2009-09-18, under 510(k) number K092653.

Who is the listed applicant for VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8?

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

What is the FDA product code for VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8?

The FDA product code for VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 is LHN.

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Related Devices (Code: LHN)

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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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