| K-number | K813164 |
| Device name | SYSTEK #1 EIKEN |
| Applicant | Syn-Kit, Inc. |
| Product code | JSS |
| Device class | Class I |
| Decision date | Dec 31, 1981 |
| Decision | Substantially Equivalent |
| Regulation | 866.2660 |
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