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FDA 510(k)

WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED

K-Number: K971028 · 1998-03-02

ApplicantWorlds-Best Gummivarefabrik A/S
Decision Date1998-03-02
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED is the device name listed in this FDA 510(k) record. The listed applicant is Worlds-Best Gummivarefabrik A/S. It received FDA 510(k) clearance on 1998-03-02 under 510(k) number K971028. 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 WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED?

WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED is a medical device that received FDA 510(k) clearance on 1998-03-02. The listed applicant is Worlds-Best Gummivarefabrik A/S. The 510(k) number is K971028.

When did WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED receive FDA 510(k) clearance?

WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED received FDA 510(k) clearance on 1998-03-02, under 510(k) number K971028.

Who is the listed applicant for WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED?

The FDA 510(k) record lists Worlds-Best Gummivarefabrik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED?

The FDA product code for WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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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