The following data is part of a premarket notification filed by Tpl-cordis, Inc. with the FDA for Multicor And Pacemakers.
Device ID | K880898 |
510k Number | K880898 |
Device Name: | MULTICOR AND PACEMAKERS |
Classification | Implantable Pacemaker Pulse-generator |
Applicant | TPL-CORDIS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
Contact | W. C Nealon |
Correspondent | W. 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 | 1988-02-26 |
Decision Date | 1988-05-06 |