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FDA 510(k)

KIMONO PLUS OTHERS (MULTIPLE) CONDOMS

K-Number: K884470 · 1989-03-31

ApplicantMayer Laboratories
Decision Date1989-03-31
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KIMONO PLUS OTHERS (MULTIPLE) CONDOMS is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 1989-03-31 under 510(k) number K884470. 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 KIMONO PLUS OTHERS (MULTIPLE) CONDOMS?

KIMONO PLUS OTHERS (MULTIPLE) CONDOMS is a medical device that received FDA 510(k) clearance on 1989-03-31. The listed applicant is Mayer Laboratories. The 510(k) number is K884470.

When did KIMONO PLUS OTHERS (MULTIPLE) CONDOMS receive FDA 510(k) clearance?

KIMONO PLUS OTHERS (MULTIPLE) CONDOMS received FDA 510(k) clearance on 1989-03-31, under 510(k) number K884470.

Who is the listed applicant for KIMONO PLUS OTHERS (MULTIPLE) CONDOMS?

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 KIMONO PLUS OTHERS (MULTIPLE) CONDOMS?

The FDA product code for KIMONO PLUS OTHERS (MULTIPLE) CONDOMS is HIS.

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Other records listing Mayer Laboratories as applicant

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Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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