The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Playtex Gentle Glide, Playtex Gentle Glide Multipack Tampons.
| Device ID | K072376 |
| 510k Number | K072376 |
| Device Name: | PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-24 |
| Decision Date | 2007-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10078300099274 | K072376 | 000 |