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FDA 510(k)

BILLY BOY MALE LATEX CONDOM

K-Number: K111093 · 2011-06-03

ApplicantMapa GmbH
Decision Date2011-06-03
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BILLY BOY MALE LATEX CONDOM is the device name listed in this FDA 510(k) record. The listed applicant is Mapa GmbH. It received FDA 510(k) clearance on 2011-06-03 under 510(k) number K111093. 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 BILLY BOY MALE LATEX CONDOM?

BILLY BOY MALE LATEX CONDOM is a medical device that received FDA 510(k) clearance on 2011-06-03. The listed applicant is Mapa GmbH. The 510(k) number is K111093.

When did BILLY BOY MALE LATEX CONDOM receive FDA 510(k) clearance?

BILLY BOY MALE LATEX CONDOM received FDA 510(k) clearance on 2011-06-03, under 510(k) number K111093.

Who is the listed applicant for BILLY BOY MALE LATEX CONDOM?

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

What is the FDA product code for BILLY BOY MALE LATEX CONDOM?

The FDA product code for BILLY BOY MALE LATEX CONDOM 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 Mapa GmbH 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.

K121478NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMPK101157E-BASIC SINGLE BREAST PUMP

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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