INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY— 510(k) K970791

Name: FDA 510(k) clearance K970791
Creator: U.S. Food and Drug Administration
Published: 1997-06-03

Substantially Equivalent

Custom Services Intl., Inc.

FDA 510(k) clearance K970791 for INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY, Substantially Equivalent on 1997-06-03. Applicant: Custom Services Intl., Inc.. Device class: 2.

Clearance details

Applicant: Custom Services Intl., Inc.
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 1997-03-04
Decision date: 1997-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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More clearances from Custom Services Intl., Inc.

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K972429 — INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-91997-09-10
K972430 — EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-91997-09-10
K972428 — EXTRAWEAR, GENTLEMEN'S CHOICE1997-08-25
K972427 — INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK1997-08-20
K970767 — CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH1997-06-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.