The following data is part of a premarket notification filed by Intl. Playtex, Inc. with the FDA for Playtex Light'n Gentle Unscented/deodorant/mini Ta.
| Device ID | K854258 |
| 510k Number | K854258 |
| Device Name: | PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | INTL. PLAYTEX, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07652 |
| Contact | Irwin Butensky |
| Correspondent | Irwin Butensky INTL. PLAYTEX, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07652 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-22 |
| Decision Date | 1985-11-21 |