The following data is part of a premarket notification filed by Playtex Family Products, Inc. with the FDA for Scented Or Scented Deodorized, Unscented Tampons.
| Device ID | K897012 |
| 510k Number | K897012 |
| Device Name: | SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PLAYTEX FAMILY PRODUCTS, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07653 |
| Contact | Butensky, Phd |
| Correspondent | Butensky, Phd PLAYTEX FAMILY PRODUCTS, 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 | 1989-12-20 |
| Decision Date | 1989-12-22 |