The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Pacing Leads Focus T81,t81f,t82f,t83,t83f,t84f.
| Device ID | K884394 |
| 510k Number | K884394 |
| Device Name: | PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F |
| Classification | Permanent Pacemaker Electrode |
| Applicant | ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Contact | Paul Kohl |
| Correspondent | Paul Kohl ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-14 |
| Decision Date | 1988-12-08 |