Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K951489 |
Device Name |
MRI'S ALL SILICONE GASTROSTOMY TUBE |
Applicant |
MANUFACTURING & RESEARCH, INC. |
P.O. BOX 2308 |
1247 FLORIDA AVENUE |
PALM HARBOR,
FL
34682 -2308
|
|
Applicant Contact |
PATRICK J LAMB |
Correspondent |
MANUFACTURING & RESEARCH, INC. |
P.O. BOX 2308 |
1247 FLORIDA AVENUE |
PALM HARBOR,
FL
34682 -2308
|
|
Correspondent Contact |
PATRICK J LAMB |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/31/1995 |
Decision Date | 06/07/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|