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FDA 510(k)

CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)

K-Number: K872356 · 1988-04-06

ApplicantMayer Laboratories
Decision Date1988-04-06
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) is the device name listed in this FDA 510(k) record. The listed applicant is Mayer Laboratories. It received FDA 510(k) clearance on 1988-04-06 under 510(k) number K872356. 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 CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)?

CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) is a medical device that received FDA 510(k) clearance on 1988-04-06. The listed applicant is Mayer Laboratories. The 510(k) number is K872356.

When did CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) receive FDA 510(k) clearance?

CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) received FDA 510(k) clearance on 1988-04-06, under 510(k) number K872356.

Who is the listed applicant for CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)?

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 CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)?

The FDA product code for CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) is HIS.

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Other records listing Mayer Laboratories as applicant

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.

K252158Sagami Original 002 Polyurethane Male CondomK001974EZ-ON CONDOMK946374KIMONO MICROTHINK946376MAXXK943064KIMONO (CONDOMS)K925869SHEATHES, STERILE SHEATHES

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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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