Clearance Summary
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY received FDA 510(k) clearance under submission number K970791, sponsored by Custom Services Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1997-06-03.
- Submission: K970791
- Applicant / Sponsor: Custom Services Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5310
- Decision date: 1997-06-03
Classification & Regulation
This clearance is catalogued under FDA product code LTZ and 21 CFR 884.5310, within the Obstetrics/Gynecology review panel as a Class II device.