| K-number | K822449 |
| Device name | TPK 1980/1 |
| Applicant | Plantex USA, Inc. |
| Product code | LCX |
| Device class | Class II |
| Decision date | Oct 27, 1982 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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