| K-number | K953541 |
| Device name | INSTANT COLDGEL |
| Applicant | Prism Technologies, Inc. |
| Product code | IMD |
| Device class | Class I |
| Decision date | Oct 5, 1995 |
| Decision | Substantially Equivalent |
| Regulation | 890.5710 |
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