The following data is part of a premarket notification filed by Personal Products Co. with the FDA for O.b. Tampon.
| Device ID | K941863 |
| 510k Number | K941863 |
| Device Name: | O.B. TAMPON |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | PERSONAL PRODUCTS CO. P.O. BOX 900 Milltown, NJ 08850 -0900 |
| Contact | R. A Petrone |
| Correspondent | R. A Petrone PERSONAL PRODUCTS CO. P.O. BOX 900 Milltown, NJ 08850 -0900 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-15 |
| Decision Date | 1994-06-27 |