Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K990127 |
Device Name |
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD) |
Applicant |
CORPAK MEDSYSTEMS |
100 CHADDICK DR. |
WHEELING,
IL
60090
|
|
Applicant Contact |
STEPHANIE WASIELEWSKI |
Correspondent |
CORPAK MEDSYSTEMS |
100 CHADDICK DR. |
WHEELING,
IL
60090
|
|
Correspondent Contact |
STEPHANIE WASIELEWSKI |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 01/13/1999 |
Decision Date | 02/10/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|