| K-number | K830504 |
| Device name | SURGITEK ULTRA-LO CUFF |
| Applicant | Mec/Surgitek Products |
| Product code | BTR |
| Device class | Class II |
| Decision date | Apr 12, 1983 |
| Decision | Substantially Equivalent |
| Regulation | 868.5730 |
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