510(k) K020202

PLAYTEX DEODORANT TAMPONS, MODEL 34702 by Playtex Products, Inc. — Product Code HIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2002
Date Received
January 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tampon, Menstrual, Scented, Scented-Deodorized
Device Class
Class II
Regulation Number
884.5460
Review Panel
OB
Submission Type

A scented or scented-deodorized menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.