The following data is part of a premarket notification filed by Personal Products Co. with the FDA for O.b. Applicator Tampons, O.b. Tampons.
| Device ID | K991118 |
| 510k Number | K991118 |
| Device Name: | O.B. APPLICATOR TAMPONS, O.B. TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | PERSONAL PRODUCTS CO. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Contact | Ralph Petrone |
| Correspondent | Ralph Petrone PERSONAL PRODUCTS CO. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-06-29 |
| Summary: | summary |