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FDA 510(k)

ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS

K-Number: K884469 · 1989-03-31

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

Device Summary

ORION PLUS W/NONOXYNOL-9 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 K884469. 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 ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS?

ORION PLUS W/NONOXYNOL-9 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 K884469.

When did ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS receive FDA 510(k) clearance?

ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS received FDA 510(k) clearance on 1989-03-31, under 510(k) number K884469.

Who is the listed applicant for ORION PLUS W/NONOXYNOL-9 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 ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS?

The FDA product code for ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS is HIS.

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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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