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FDA 510(k)

CAUTION CONDOMS

K-Number: K033163 · 2004-04-27

ApplicantRichard Van Haussen America, Inc.
Decision Date2004-04-27
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CAUTION CONDOMS is the device name listed in this FDA 510(k) record. The listed applicant is Richard Van Haussen America, Inc.. It received FDA 510(k) clearance on 2004-04-27 under 510(k) number K033163. The device is classified under product code LTZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAUTION CONDOMS?

CAUTION CONDOMS is a medical device that received FDA 510(k) clearance on 2004-04-27. The listed applicant is Richard Van Haussen America, Inc.. The 510(k) number is K033163.

When did CAUTION CONDOMS receive FDA 510(k) clearance?

CAUTION CONDOMS received FDA 510(k) clearance on 2004-04-27, under 510(k) number K033163.

Who is the listed applicant for CAUTION CONDOMS?

The FDA 510(k) record lists Richard Van Haussen America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAUTION CONDOMS?

The FDA product code for CAUTION CONDOMS is LTZ.

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Related Devices (Code: LTZ)

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.

K012969DOUBLE SPRINGERS NONOXNOL 9 CONDOMMedtech Products , Ltd.K010178SPERMICIDAL LUBRICATED MALE LATEX CONDOMInnolatex Sdn. BhdK003375CONTROL MALE CONDOMS OF NATURAL RUBBER LATEXTecnilatex S.A.K001978'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9Thai Nippon Rubber Industry Co., Ltd.K001377SPERMICIDAL LUBRICATED MALE LATEX CONDOMPleasure Latex Products Sdn. Bhd.K992438INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)Indus Medicare , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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