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FDA 510(k)

LABELLING MODIFICATION TO MAXX PLUS

K-Number: K904453 · 1990-11-23

ApplicantMayer Laboratories
Decision Date1990-11-23
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LABELLING MODIFICATION TO MAXX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 1990-11-23 under 510(k) number K904453. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABELLING MODIFICATION TO MAXX PLUS?

LABELLING MODIFICATION TO MAXX PLUS is a medical device that received FDA 510(k) clearance on 1990-11-23. The listed applicant is Mayer Laboratories. The 510(k) number is K904453.

When did LABELLING MODIFICATION TO MAXX PLUS receive FDA 510(k) clearance?

LABELLING MODIFICATION TO MAXX PLUS received FDA 510(k) clearance on 1990-11-23, under 510(k) number K904453.

Who is the listed applicant for LABELLING MODIFICATION TO MAXX PLUS?

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 LABELLING MODIFICATION TO MAXX PLUS?

The FDA product code for LABELLING MODIFICATION TO MAXX PLUS is HIS.

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Other records listing Mayer Laboratories as applicant

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Related Devices (Code: HIS)

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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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