Sebia · Class II · Cleared Jun 13, 2001
| K-number | K011113 |
| Device name | HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) |
| Applicant | Sebia |
| Product code | CIN |
| Device class | Class II |
| Decision date | Jun 13, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 862.1050 |
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