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FDA 510(k)

PLASMALUXLS

K-Number: K100628 · 2010-11-24

ApplicantDaavlin Distributing Co.
Decision Date2010-11-24
Product CodeONE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLASMALUXLS is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Co.. It received FDA 510(k) clearance on 2010-11-24 under 510(k) number K100628. The device is classified under product code ONE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMALUXLS?

PLASMALUXLS is a medical device that received FDA 510(k) clearance on 2010-11-24. The listed applicant is Daavlin Distributing Co.. The 510(k) number is K100628.

When did PLASMALUXLS receive FDA 510(k) clearance?

PLASMALUXLS received FDA 510(k) clearance on 2010-11-24, under 510(k) number K100628.

Who is the listed applicant for PLASMALUXLS?

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

What is the FDA product code for PLASMALUXLS?

The FDA product code for PLASMALUXLS is ONE.

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Related Devices (Code: ONE)

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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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