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FDA 510(k)

XL-4 PAGODA (CONDOMS)

K-Number: K874851 · 1988-01-21

ApplicantMayer Laboratories
Decision Date1988-01-21
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

XL-4 PAGODA (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 1988-01-21 under 510(k) number K874851. 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 XL-4 PAGODA (CONDOMS)?

XL-4 PAGODA (CONDOMS) is a medical device that received FDA 510(k) clearance on 1988-01-21. The listed applicant is Mayer Laboratories. The 510(k) number is K874851.

When did XL-4 PAGODA (CONDOMS) receive FDA 510(k) clearance?

XL-4 PAGODA (CONDOMS) received FDA 510(k) clearance on 1988-01-21, under 510(k) number K874851.

Who is the listed applicant for XL-4 PAGODA (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 XL-4 PAGODA (CONDOMS)?

The FDA product code for XL-4 PAGODA (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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