The following data is part of a premarket notification filed by Tpl-cordis, Inc. with the FDA for Modified Multicor And Omni-stanicor Pacemakers.
| Device ID | K873158 |
| 510k Number | K873158 |
| Device Name: | MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | TPL-CORDIS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | William C Nealon |
| Correspondent | William C Nealon TPL-CORDIS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-10 |
| Decision Date | 1988-01-07 |