The following data is part of a premarket notification filed by Mcneil-ppc, Inc. with the FDA for O.b. Tampons.
| Device ID | K023789 |
| 510k Number | K023789 |
| Device Name: | O.B. TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | MCNEIL-PPC, INC. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Contact | Diana L.b. Uhl |
| Correspondent | Diana L.b. Uhl MCNEIL-PPC, INC. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-13 |
| Decision Date | 2002-12-06 |
| Summary: | summary |