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FDA 510(k)

TUSTEX FLAVORED CONDOMS

K-Number: K970633 · 1997-03-21

ApplicantLine One Laboratories
Decision Date1997-03-21
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TUSTEX FLAVORED CONDOMS 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 1997-03-21 under 510(k) number K970633. 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 TUSTEX FLAVORED CONDOMS?

TUSTEX FLAVORED CONDOMS is a medical device that received FDA 510(k) clearance on 1997-03-21. The listed applicant is Line One Laboratories. The 510(k) number is K970633.

When did TUSTEX FLAVORED CONDOMS receive FDA 510(k) clearance?

TUSTEX FLAVORED CONDOMS received FDA 510(k) clearance on 1997-03-21, under 510(k) number K970633.

Who is the listed applicant for TUSTEX FLAVORED CONDOMS?

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 TUSTEX FLAVORED CONDOMS?

The FDA product code for TUSTEX FLAVORED CONDOMS is HIS.

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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 COLORK964598TRUSTEX COLA FLAVORD CONDOMK964599TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLORK964591TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE 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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