The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Intermedics Model 366-15 Vs 1 Header Plug.
| Device ID | K920530 |
| 510k Number | K920530 |
| Device Name: | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Contact | Alaine Medio |
| Correspondent | Alaine Medio INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-05 |
| Decision Date | 1992-03-17 |