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 |