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FDA 510(k)

L-VARLOCK

K-Number: K080537 · 2008-06-30

ApplicantKiscomedica S.A.
Decision Date2008-06-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

L-VARLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Kiscomedica S.A.. It received FDA 510(k) clearance on 2008-06-30 under 510(k) number K080537. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L-VARLOCK?

L-VARLOCK is a medical device that received FDA 510(k) clearance on 2008-06-30. The listed applicant is Kiscomedica S.A.. The 510(k) number is K080537.

When did L-VARLOCK receive FDA 510(k) clearance?

L-VARLOCK received FDA 510(k) clearance on 2008-06-30, under 510(k) number K080537.

Who is the listed applicant for L-VARLOCK?

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

What is the FDA product code for L-VARLOCK?

The FDA product code for L-VARLOCK is MAX.

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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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