| K-number | K862936 |
| Device name | NEWMAN CANNULAE SYSTEM (NCS) |
| Applicant | Byron Medical |
| Product code | GEA |
| Device class | Class I |
| Decision date | Aug 14, 1986 |
| Decision | Substantially Equivalent for Some Indications |
| Regulation | 878.4800 |
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