| K-number | K032644 |
| Device name | KOLPEXIN SPHERE |
| Applicant | Adamed , Ltd. |
| Product code | HHW |
| Device class | Class II |
| Decision date | May 28, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 884.3575 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov