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FDA 510(k)

MULTIPLE NAME MODEL MULTIPLE

K-Number: K093759 · 2010-02-19

ApplicantGx Corporation Sdn Bhd (Plant 1)
Decision Date2010-02-19
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MULTIPLE NAME MODEL MULTIPLE is the device name listed in this FDA 510(k) record. The listed applicant is Gx Corporation Sdn Bhd (Plant 1). It received FDA 510(k) clearance on 2010-02-19 under 510(k) number K093759. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE NAME MODEL MULTIPLE?

MULTIPLE NAME MODEL MULTIPLE is a medical device that received FDA 510(k) clearance on 2010-02-19. The listed applicant is Gx Corporation Sdn Bhd (Plant 1). The 510(k) number is K093759.

When did MULTIPLE NAME MODEL MULTIPLE receive FDA 510(k) clearance?

MULTIPLE NAME MODEL MULTIPLE received FDA 510(k) clearance on 2010-02-19, under 510(k) number K093759.

Who is the listed applicant for MULTIPLE NAME MODEL MULTIPLE?

The FDA 510(k) record lists Gx Corporation Sdn Bhd (Plant 1) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIPLE NAME MODEL MULTIPLE?

The FDA product code for MULTIPLE NAME MODEL MULTIPLE is LZA.

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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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