The following data is part of a premarket notification filed by Talbot S. Lindstrom with the FDA for Ysanpoint) (menstrual) Digital Tampon.
| Device ID | K962712 |
| 510k Number | K962712 |
| Device Name: | YSANPOINT) (MENSTRUAL) DIGITAL TAMPON |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TALBOT S. LINDSTROM SERGELS TORG 12 P.O. BOX 1432 Stockholm, SE S-11184 |
| Contact | Talbot S Lindstrom |
| Correspondent | Talbot S Lindstrom TALBOT S. LINDSTROM SERGELS TORG 12 P.O. BOX 1432 Stockholm, SE S-11184 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-12 |
| Decision Date | 1996-09-10 |
| Summary: | summary |