| K-number | K811697 |
| Device name | GUAMSTAINER |
| Applicant | Tomtec |
| Product code | KPA |
| Device class | Class I |
| Decision date | Jul 2, 1981 |
| Decision | Substantially Equivalent |
| Regulation | 864.3800 |
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