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FDA 510(k)

DIGITEX, DIGITEX HYPOALLERGENIC

K-Number: K926049 · 1993-07-22

ApplicantMayer Laboratories
Decision Date1993-07-22
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DIGITEX, DIGITEX HYPOALLERGENIC is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 1993-07-22 under 510(k) number K926049. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITEX, DIGITEX HYPOALLERGENIC?

DIGITEX, DIGITEX HYPOALLERGENIC is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Mayer Laboratories. The 510(k) number is K926049.

When did DIGITEX, DIGITEX HYPOALLERGENIC receive FDA 510(k) clearance?

DIGITEX, DIGITEX HYPOALLERGENIC received FDA 510(k) clearance on 1993-07-22, under 510(k) number K926049.

Who is the listed applicant for DIGITEX, DIGITEX HYPOALLERGENIC?

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

What is the FDA product code for DIGITEX, DIGITEX HYPOALLERGENIC?

The FDA product code for DIGITEX, DIGITEX HYPOALLERGENIC is LYY.

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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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