Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K880232 |
Device Name |
NH REPLACEMENT GASTROSTOMY KIT |
Applicant |
BIOSEARCH MEDICAL PRODUCTS, INC. |
35 INDUSTRIAL PKWY. |
P.O. BOX 1700 |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
JOHN CARSELLO |
Correspondent |
BIOSEARCH MEDICAL PRODUCTS, INC. |
35 INDUSTRIAL PKWY. |
P.O. BOX 1700 |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
JOHN CARSELLO |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 01/20/1988 |
Decision Date | 03/03/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|