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FDA 510(k)

PLASMACURE BXE

K-Number: K033795 · 2003-12-19

ApplicantEele Laboratories, LLC
Decision Date2003-12-19
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLASMACURE BXE is the device name listed in this FDA 510(k) record. The listed applicant is Eele Laboratories, LLC. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K033795. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMACURE BXE?

PLASMACURE BXE is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Eele Laboratories, LLC. The 510(k) number is K033795.

When did PLASMACURE BXE receive FDA 510(k) clearance?

PLASMACURE BXE received FDA 510(k) clearance on 2003-12-19, under 510(k) number K033795.

Who is the listed applicant for PLASMACURE BXE?

The FDA 510(k) record lists Eele Laboratories, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLASMACURE BXE?

The FDA product code for PLASMACURE BXE is EBZ.

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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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