The following data is part of a premarket notification filed by Personal Products Co. with the FDA for O.b. Applicator Tampons.
| Device ID | K953638 |
| 510k Number | K953638 |
| Device Name: | O.B. APPLICATOR TAMPONS |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PERSONAL PRODUCTS CO. VAN LIEW AVE. P.O. BOX 900 Milltown, NJ 08850 |
| Contact | Ralph A Petrone |
| Correspondent | Ralph A Petrone PERSONAL PRODUCTS CO. VAN LIEW AVE. P.O. BOX 900 Milltown, NJ 08850 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-04 |
| Decision Date | 1995-10-20 |