Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K875232 |
Device Name |
INTRO-REDUCER (NASOGASTRIC TUBE) |
Applicant |
HEALTH IMPROVEMENT ASSOC. |
12555 WEST FREELAND RD. |
FREELAND,
MI
48623
|
|
Applicant Contact |
ALEXANDER BOMMARITO |
Correspondent |
HEALTH IMPROVEMENT ASSOC. |
12555 WEST FREELAND RD. |
FREELAND,
MI
48623
|
|
Correspondent Contact |
ALEXANDER BOMMARITO |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/22/1987 |
Decision Date | 06/02/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|