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FDA 510(k)

RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE

K-Number: K945930 · 1995-12-19

ApplicantLine One Laboratories & Trading Co.
Decision Date1995-12-19
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE is the device name listed in this FDA 510(k) record. The listed applicant is Line One Laboratories & Trading Co.. It received FDA 510(k) clearance on 1995-12-19 under 510(k) number K945930. 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 RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE?

RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE is a medical device that received FDA 510(k) clearance on 1995-12-19. The listed applicant is Line One Laboratories & Trading Co.. The 510(k) number is K945930.

When did RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE receive FDA 510(k) clearance?

RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE received FDA 510(k) clearance on 1995-12-19, under 510(k) number K945930.

Who is the listed applicant for RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE?

The FDA 510(k) record lists Line One Laboratories & Trading Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE?

The FDA product code for RIA LATEX CONDOM WITH SPERMICIDE, RIA COLOR CONDOM WITH SPERMICIDE is HIS.

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.

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Other records listing Line One Laboratories & Trading Co. 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.

K946103TRUSTEX FLAVOR CONDON IN COLORSK944786RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK)

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.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.

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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