The following data is part of a premarket notification filed by Tpl-cordis, Inc. with the FDA for Vicor, Model 410a.
Device ID | K873202 |
510k Number | K873202 |
Device Name: | VICOR, MODEL 410A |
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 | 1987-08-13 |
Decision Date | 1987-10-15 |