EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9— 510(k) K972430
Substantially EquivalentCustom Services Intl., Inc.
FDA 510(k) clearance K972430 for EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9, Substantially Equivalent on 1997-09-10. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Las Vegas, NV, US
Recent devices under product code LTZ
view allMore clearances from Custom Services Intl., Inc.
view all- K972429 — INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
- K972428 — EXTRAWEAR, GENTLEMEN'S CHOICE
- K972427 — INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK
- K970791 — INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY
- K970767 — CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH
Data sourced from openFDA. This site is unofficial and independent of the FDA.