510(k) K023803 ยท DTB Permanent Pacemaker Electrode
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Dec 11, 2002 |
| Received | Nov 14, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023803
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.