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FDA 510(k)

SAFECON CONDOMS W/SPERMICIDAL LUBRICANT

K-Number: K883524 · 1989-03-29

ApplicantQuality Synthetics Intl, Inc.
Decision Date1989-03-29
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SAFECON CONDOMS W/SPERMICIDAL LUBRICANT 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 1989-03-29 under 510(k) number K883524. 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 W/SPERMICIDAL LUBRICANT?

SAFECON CONDOMS W/SPERMICIDAL LUBRICANT is a medical device that received FDA 510(k) clearance on 1989-03-29. The listed applicant is Quality Synthetics Intl, Inc.. The 510(k) number is K883524.

When did SAFECON CONDOMS W/SPERMICIDAL LUBRICANT receive FDA 510(k) clearance?

SAFECON CONDOMS W/SPERMICIDAL LUBRICANT received FDA 510(k) clearance on 1989-03-29, under 510(k) number K883524.

Who is the listed applicant for SAFECON CONDOMS W/SPERMICIDAL LUBRICANT?

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 W/SPERMICIDAL LUBRICANT?

The FDA product code for SAFECON CONDOMS W/SPERMICIDAL LUBRICANT 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 COLORK884454SAFECON CONDOMS - RIBBEDK874399SAFECON 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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