The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Modification To: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons.
| Device ID | K070745 |
| 510k Number | K070745 |
| Device Name: | MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC 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 | 2007-03-19 |
| Decision Date | 2007-04-13 |
| Summary: | summary |