Device Classification Name |
Tube, Gastro-Enterostomy
|
510(k) Number |
K900884 |
Device Name |
P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY |
Applicant |
APPLIED MEDICAL TECHNOLOGIES |
6100 WEST CREEK RD. |
SUITE 25 |
INDEPENDENCE,
OH
44131
|
|
Applicant Contact |
PAT GILPIN |
Correspondent |
APPLIED MEDICAL TECHNOLOGIES |
6100 WEST CREEK RD. |
SUITE 25 |
INDEPENDENCE,
OH
44131
|
|
Correspondent Contact |
PAT GILPIN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 02/26/1990 |
Decision Date | 07/02/1990 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|