The following data is part of a premarket notification filed by Adamed Ltd. with the FDA for Kolpexin Sphere.
| Device ID | K032644 |
| 510k Number | K032644 |
| Device Name: | KOLPEXIN SPHERE |
| Classification | Pessary, Vaginal |
| Applicant | ADAMED LTD. 3432 BROOKSHIRE DR. Plano, TX 75075 |
| Contact | Norman I Bruckner |
| Correspondent | Norman I Bruckner ADAMED LTD. 3432 BROOKSHIRE DR. Plano, TX 75075 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-27 |
| Decision Date | 2004-05-28 |
| Summary: | summary |