The following data is part of a premarket notification filed by Intl. Playtex, Inc. with the FDA for Playtex Tampons.
| Device ID | K861738 |
| 510k Number | K861738 |
| Device Name: | PLAYTEX TAMPONS |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | INTL. PLAYTEX, INC. 700 FAIRFIELD AVE. P.O. BOX 10064 Stamford, CT 06904 |
| Contact | Bruce J Wendel |
| Correspondent | Bruce J Wendel INTL. PLAYTEX, INC. 700 FAIRFIELD AVE. P.O. BOX 10064 Stamford, CT 06904 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1986-07-22 |