The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Epicath.
| Device ID | K862358 |
| 510k Number | K862358 |
| Device Name: | EPICATH |
| Classification | Set, Anesthesia, Obstetric |
| Applicant | HDC CORP. 2551 CASEY AVE. Mountain View, CA 94043 |
| Contact | William J Schroder |
| Correspondent | William J Schroder HDC CORP. 2551 CASEY AVE. Mountain View, CA 94043 |
| Product Code | KNE |
| CFR Regulation Number | 884.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-23 |
| Decision Date | 1986-07-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EPICATH 77160001 not registered Dead/Abandoned |
SentreHEART 2007-04-18 |