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FDA 510(k)

EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9

K-Number: K972430 · 1997-09-10

ApplicantCustom Services Intl., Inc.
Decision Date1997-09-10
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 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 1997-09-10 under 510(k) number K972430. The device is classified under product code LTZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9?

EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 is a medical device that received FDA 510(k) clearance on 1997-09-10. The listed applicant is Custom Services Intl., Inc.. The 510(k) number is K972430.

When did EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 receive FDA 510(k) clearance?

EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 received FDA 510(k) clearance on 1997-09-10, under 510(k) number K972430.

Who is the listed applicant for EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9?

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 EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9?

The FDA product code for EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 is LTZ.

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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-9K972428EXTRAWEAR, GENTLEMEN'S CHOICEK972427INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINKK970791INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTYK970767CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTHK963321OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN

View all 9 devices →

Related Devices (Code: LTZ)

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.

K033163CAUTION CONDOMSRichard Van Haussen America, Inc.K012969DOUBLE SPRINGERS NONOXNOL 9 CONDOMMedtech Products , Ltd.K010178SPERMICIDAL LUBRICATED MALE LATEX CONDOMInnolatex Sdn. BhdK003375CONTROL MALE CONDOMS OF NATURAL RUBBER LATEXTecnilatex S.A.K001978'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9Thai Nippon Rubber Industry Co., Ltd.K001377SPERMICIDAL LUBRICATED MALE LATEX CONDOMPleasure Latex Products Sdn. Bhd.

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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