The following data is part of a premarket notification filed by Sanpoint Ab with the FDA for Sanpoint Menstrual Tampon.
| Device ID | K961926 |
| 510k Number | K961926 |
| Device Name: | SANPOINT MENSTRUAL TAMPON |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | SANPOINT AB P.O. BOX 55 Mariefred, SE S-647 |
| Contact | Hans Feikes De Groot |
| Correspondent | Hans Feikes De Groot SANPOINT AB P.O. BOX 55 Mariefred, SE S-647 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-17 |
| Decision Date | 1996-07-15 |
| Summary: | summary |