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FDA 510(k)

WRINKLE CHAPEAU BLACKY

K-Number: K842502 · 1984-09-21

ApplicantCircle Rubber Corp.
Decision Date1984-09-21
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WRINKLE CHAPEAU BLACKY is the device name listed in this FDA 510(k) record. The listed applicant is Circle Rubber Corp.. It received FDA 510(k) clearance on 1984-09-21 under 510(k) number K842502. 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 WRINKLE CHAPEAU BLACKY?

WRINKLE CHAPEAU BLACKY is a medical device that received FDA 510(k) clearance on 1984-09-21. The listed applicant is Circle Rubber Corp.. The 510(k) number is K842502.

When did WRINKLE CHAPEAU BLACKY receive FDA 510(k) clearance?

WRINKLE CHAPEAU BLACKY received FDA 510(k) clearance on 1984-09-21, under 510(k) number K842502.

Who is the listed applicant for WRINKLE CHAPEAU BLACKY?

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

What is the FDA product code for WRINKLE CHAPEAU BLACKY?

The FDA product code for WRINKLE CHAPEAU BLACKY 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 Circle Rubber Corp. 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.

K890407THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATIONK883467THE SAXON SPERMICIDAL CONDOMK872736PROPHYLACTIC (CONDOM)K813172CONDOM-MULTIPAL STYLES

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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