The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Model 366-14 Intermedics Lead Connector Cap.
Device ID | K864738 |
510k Number | K864738 |
Device Name: | MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP |
Classification | Permanent Pacemaker Electrode |
Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
Contact | Ken Bishop |
Correspondent | Ken Bishop INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
Product Code | DTB |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-04 |
Decision Date | 1987-01-06 |