Device Classification Name |
System, Gastrointestinal Motility (Electrical)
|
510(k) Number |
K973844 |
Device Name |
GASTRIC AND RECTAL CATHETERS |
Applicant |
G & J ELECTRONICS, INC. |
6 DORNFELL ST. |
TORONTO, ONTARIO,
CA
M2R 2Y6
|
|
Applicant Contact |
SAM JUNDLER |
Correspondent |
G & J ELECTRONICS, INC. |
6 DORNFELL ST. |
TORONTO, ONTARIO,
CA
M2R 2Y6
|
|
Correspondent Contact |
SAM JUNDLER |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 10/08/1997 |
Decision Date | 06/04/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|