The following data is part of a premarket notification filed by Playtex, Inc. with the FDA for Playtex Portable Non-deod. & Deod Regular & Super.
| Device ID | K881057 |
| 510k Number | K881057 |
| Device Name: | PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PLAYTEX, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07653 |
| Contact | Butensky, Phd |
| Correspondent | Butensky, Phd PLAYTEX, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07653 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-11 |
| Decision Date | 1988-03-22 |