Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K931921 |
Device Name |
CORPAK GASTROSTOMY TUBE |
Applicant |
CORPAK CO. |
100 CHADDICK DR. |
WHEELING,
IL
60090
|
|
Applicant Contact |
ROBERT E BOOTH |
Correspondent |
CORPAK CO. |
100 CHADDICK DR. |
WHEELING,
IL
60090
|
|
Correspondent Contact |
ROBERT E BOOTH |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/16/1993 |
Decision Date | 06/09/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|