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FDA 510(k)

CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH

K-Number: K970767 · 1997-06-02

ApplicantCustom Services Intl., Inc.
Decision Date1997-06-02
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH is the device name listed in this FDA 510(k) record. The listed applicant is Custom Services Intl., Inc.. It received FDA 510(k) clearance on 1997-06-02 under 510(k) number K970767. 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 CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH?

CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH is a medical device that received FDA 510(k) clearance on 1997-06-02. The listed applicant is Custom Services Intl., Inc.. The 510(k) number is K970767.

When did CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH receive FDA 510(k) clearance?

CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH received FDA 510(k) clearance on 1997-06-02, under 510(k) number K970767.

Who is the listed applicant for CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH?

The FDA 510(k) record lists Custom Services Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH?

The FDA product code for CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH is HIS.

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Other records listing Custom Services 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.

K972429INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9K972430EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9K972428EXTRAWEAR, GENTLEMEN'S CHOICEK972427INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINKK970791INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTYK963321OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN

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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

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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