The following data is part of a premarket notification filed by Intl. Playtex, Inc. with the FDA for Playtex Super Plus Tampons & Deodorant Tampons.
| Device ID | K851355 |
| 510k Number | K851355 |
| Device Name: | PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| 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 | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-04 |
| Decision Date | 1985-04-12 |