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FDA 510(k)

HEADFIRST (CONDOM)

K-Number: K874921 · 1988-05-13

ApplicantStual Products, Inc.
Decision Date1988-05-13
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HEADFIRST (CONDOM) is the device name listed in this FDA 510(k) record. The listed applicant is Stual Products, Inc.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K874921. 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 HEADFIRST (CONDOM)?

HEADFIRST (CONDOM) is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Stual Products, Inc.. The 510(k) number is K874921.

When did HEADFIRST (CONDOM) receive FDA 510(k) clearance?

HEADFIRST (CONDOM) received FDA 510(k) clearance on 1988-05-13, under 510(k) number K874921.

Who is the listed applicant for HEADFIRST (CONDOM)?

The FDA 510(k) record lists Stual Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEADFIRST (CONDOM)?

The FDA product code for HEADFIRST (CONDOM) is HIS.

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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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