Clearance Summary
PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS received FDA 510(k) clearance under submission number K971547, sponsored by Playtex Products, 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 1997-06-19.
- Submission: K971547
- Applicant / Sponsor: Playtex Products, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5460
- Decision date: 1997-06-19
Classification & Regulation
This clearance is catalogued under FDA product code HIL and 21 CFR 884.5460, within the Obstetrics/Gynecology review panel as a Class II device.