The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Multipace.
Device ID | K934785 |
510k Number | K934785 |
Device Name: | MULTIPACE |
Classification | Electrode, Pacemaker, Temporary |
Applicant | ELECTRO-CATHETER CORP. 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
Contact | Lorraine T Montemurro |
Correspondent | Lorraine T Montemurro ELECTRO-CATHETER CORP. 2100 FELVER COURT P.O. BOX 1214C Rahway, NJ 07065 |
Product Code | LDF |
CFR Regulation Number | 870.3680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-05 |
Decision Date | 1995-07-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MULTIPACE 74244604 1809987 Dead/Cancelled |
ELECTRO-CATHETER 1992-02-10 |