The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Bk-a; Bk-b; Bk-is Sealing Cap.
| Device ID | K970204 |
| 510k Number | K970204 |
| Device Name: | BK-A; BK-B; BK-IS SEALING CAP |
| Classification | Pacemaker Lead Adaptor |
| Applicant | BIOTRONIK, INC. 6024 SW JEAN RD. B4 Lake Oswego, OR 97035 -3594 |
| Contact | Joseph J Schwoebel |
| Correspondent | Joseph J Schwoebel BIOTRONIK, INC. 6024 SW JEAN RD. B4 Lake Oswego, OR 97035 -3594 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035479000950 | K970204 | 000 |
| 04035479005894 | K970204 | 000 |
| 04035479005887 | K970204 | 000 |