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FDA 510(k)

INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY

K-Number: K970791 · 1997-06-03

ApplicantCustom Services Intl., Inc.
Decision Date1997-06-03
Product CodeLTZ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY 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 1997-06-03 under 510(k) number K970791. 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 INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY?

INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY is a medical device that received FDA 510(k) clearance on 1997-06-03. The listed applicant is Custom Services Intl., Inc.. The 510(k) number is K970791.

When did INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY receive FDA 510(k) clearance?

INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY received FDA 510(k) clearance on 1997-06-03, under 510(k) number K970791.

Who is the listed applicant for INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY?

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 INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY?

The FDA product code for INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY 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-9K972430EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9K972428EXTRAWEAR, GENTLEMEN'S CHOICEK972427INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINKK970767CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTHK963321OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN

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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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