The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Playtex Gentile Glide, Playtex Gentile Glide Multipack Tampons.
Device ID | K073662 |
510k Number | K073662 |
Device Name: | PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS |
Classification | Tampon, Menstrual, Scented, Deodorized |
Applicant | PLAYTEX PRODUCTS, INC. 804 WALKER RD. Dover, DE 19904 |
Contact | Keith Edgett |
Correspondent | Keith Edgett PLAYTEX PRODUCTS, INC. 804 WALKER RD. Dover, DE 19904 |
Product Code | HIL |
CFR Regulation Number | 884.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-26 |
Decision Date | 2008-01-17 |
Summary: | summary |