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FDA 510(k)

STOPEX-CONDOMS-

K-Number: K834591 · 1984-02-04

ApplicantTropex Worldwide, Inc.
Decision Date1984-02-04
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

STOPEX-CONDOMS- is the device name listed in this FDA 510(k) record. The listed applicant is Tropex Worldwide, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K834591. 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 STOPEX-CONDOMS-?

STOPEX-CONDOMS- is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Tropex Worldwide, Inc.. The 510(k) number is K834591.

When did STOPEX-CONDOMS- receive FDA 510(k) clearance?

STOPEX-CONDOMS- received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834591.

Who is the listed applicant for STOPEX-CONDOMS-?

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

What is the FDA product code for STOPEX-CONDOMS-?

The FDA product code for STOPEX-CONDOMS- 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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