Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K874154 |
Device Name |
ELECATH(R) TRANSESOPHAGEAL PACING CATHETER |
Applicant |
ELECTRO-CATHETER CORP. |
2100 FELVER COURT |
P.O. BOX 1214C |
RAHWAY,
NJ
07065
|
|
Applicant Contact |
RICHARD RAGULA |
Correspondent |
ELECTRO-CATHETER CORP. |
2100 FELVER COURT |
P.O. BOX 1214C |
RAHWAY,
NJ
07065
|
|
Correspondent Contact |
RICHARD RAGULA |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 10/13/1987 |
Decision Date | 04/29/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|