Device Classification Name |
system, gastrointestinal motility (electrical)
|
510(k) Number |
K004040 |
Device Name |
REDTECH GIPC 2000 |
Applicant |
RED-TECH, INC. |
27881 LA PAZ RD. |
LAGUNA NIGUEL,
CA
|
|
Applicant Contact |
GARY MOCNIK |
Correspondent |
RED-TECH, INC. |
27881 LA PAZ RD. |
LAGUNA NIGUEL,
CA
|
|
Correspondent Contact |
GARY MOCNIK |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 12/29/2000 |
Decision Date | 03/29/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|