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FDA 510(k)

SAFECON CONDOMS - RIBBED

K-Number: K884454 · 1989-04-25

ApplicantQuality Synthetics Intl, Inc.
Decision Date1989-04-25
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SAFECON CONDOMS - RIBBED is the device name listed in this FDA 510(k) record. The listed applicant is Quality Synthetics Intl, Inc.. It received FDA 510(k) clearance on 1989-04-25 under 510(k) number K884454. 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 SAFECON CONDOMS - RIBBED?

SAFECON CONDOMS - RIBBED is a medical device that received FDA 510(k) clearance on 1989-04-25. The listed applicant is Quality Synthetics Intl, Inc.. The 510(k) number is K884454.

When did SAFECON CONDOMS - RIBBED receive FDA 510(k) clearance?

SAFECON CONDOMS - RIBBED received FDA 510(k) clearance on 1989-04-25, under 510(k) number K884454.

Who is the listed applicant for SAFECON CONDOMS - RIBBED?

The FDA 510(k) record lists Quality Synthetics Intl, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFECON CONDOMS - RIBBED?

The FDA product code for SAFECON CONDOMS - RIBBED 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 Quality Synthetics Intl, Inc. 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.

K896623SAFECON CONDOMS - PINK COLORK883524SAFECON CONDOMS W/SPERMICIDAL LUBRICANTK874399SAFECON CONDOMS

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

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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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