The following data is part of a premarket notification filed by Playtex Family Products, Inc. with the FDA for Playtex Tampons #04994 Unscented & Scented.
| Device ID | K940821 |
| 510k Number | K940821 |
| Device Name: | PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PLAYTEX FAMILY PRODUCTS, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07653 |
| Contact | Irwin Butensky |
| Correspondent | Irwin Butensky 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 | 1994-02-22 |
| Decision Date | 1994-03-25 |