| K-number | K971930 |
| Device name | BK-N SEALING CAP |
| Applicant | Biotronik, Inc. |
| Product code | DTD |
| Device class | Class II |
| Decision date | Aug 14, 1997 |
| Decision | Substantially Equivalent - Subject to Tracking & PMS |
| Regulation | 870.3620 |
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