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FDA 510(k)

MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS

K-Number: K981955 · 1999-03-15

ApplicantLs Rubber Sdn Bhd
Decision Date1999-03-15
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS is the device name listed in this FDA 510(k) record. The listed applicant is Ls Rubber Sdn Bhd. It received FDA 510(k) clearance on 1999-03-15 under 510(k) number K981955. 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 MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS?

MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS is a medical device that received FDA 510(k) clearance on 1999-03-15. The listed applicant is Ls Rubber Sdn Bhd. The 510(k) number is K981955.

When did MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS receive FDA 510(k) clearance?

MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS received FDA 510(k) clearance on 1999-03-15, under 510(k) number K981955.

Who is the listed applicant for MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS?

The FDA 510(k) record lists Ls Rubber Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS?

The FDA product code for MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS is LTZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ls Rubber Sdn Bhd 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.

K020633NATURAL AND COLORED LATEX CONDOM WITH FLAVORSK980964MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS

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.

K033163CAUTION CONDOMSRichard Van Haussen America, Inc.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.

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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