The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Bk-n Sealing Cap.
| Device ID | K971930 |
| 510k Number | K971930 |
| Device Name: | BK-N SEALING CAP |
| Classification | Pacemaker Lead Adaptor |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Kenneth Jensen |
| Correspondent | Kenneth Jensen BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Se Subject To Traking & Pms (PT) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-27 |
| Decision Date | 1997-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035479000974 | K971930 | 000 |