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FDA 510(k)

THE SAFEGARD PERSONAL PROTECTION KIT

K-Number: K884692 · 1989-09-12

ApplicantThe Safegard Protection Corp.
Decision Date1989-09-12
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THE SAFEGARD PERSONAL PROTECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is The Safegard Protection Corp.. It received FDA 510(k) clearance on 1989-09-12 under 510(k) number K884692. 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 THE SAFEGARD PERSONAL PROTECTION KIT?

THE SAFEGARD PERSONAL PROTECTION KIT is a medical device that received FDA 510(k) clearance on 1989-09-12. The listed applicant is The Safegard Protection Corp.. The 510(k) number is K884692.

When did THE SAFEGARD PERSONAL PROTECTION KIT receive FDA 510(k) clearance?

THE SAFEGARD PERSONAL PROTECTION KIT received FDA 510(k) clearance on 1989-09-12, under 510(k) number K884692.

Who is the listed applicant for THE SAFEGARD PERSONAL PROTECTION KIT?

The FDA 510(k) record lists The Safegard Protection Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE SAFEGARD PERSONAL PROTECTION KIT?

The FDA product code for THE SAFEGARD PERSONAL PROTECTION KIT 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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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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