The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Playtex Ultimates Silk Glide Tampons #23094.
| Device ID | K944155 |
| 510k Number | K944155 |
| Device Name: | PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094 |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | PLAYTEX PRODUCTS, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07652 |
| Contact | Trwin Butensky |
| Correspondent | Trwin Butensky PLAYTEX PRODUCTS, 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 | 1994-08-19 |
| Decision Date | 1995-02-09 |