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FDA 510(k)

TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR

K-Number: K964591 · 1997-02-13

ApplicantLine One Laboratories
Decision Date1997-02-13
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Line One Laboratories. It received FDA 510(k) clearance on 1997-02-13 under 510(k) number K964591. 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 TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR?

TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR is a medical device that received FDA 510(k) clearance on 1997-02-13. The listed applicant is Line One Laboratories. The 510(k) number is K964591.

When did TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR receive FDA 510(k) clearance?

TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR received FDA 510(k) clearance on 1997-02-13, under 510(k) number K964591.

Who is the listed applicant for TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR?

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

What is the FDA product code for TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR?

The FDA product code for TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR 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 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.

K991892TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLORK970633TUSTEX FLAVORED CONDOMSK964598TRUSTEX COLA FLAVORD CONDOMK964599TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR

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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