Device Classification Name |
Tube, Feeding
|
510(k) Number |
K922402 |
Device Name |
4 SURE TM ENTERAL FEEDING BAG |
Applicant |
BOSTON PACIFIC MEDICAL, INC. |
451 D ST. |
SUITE 811 |
BOSTON,
MA
02210
|
|
Applicant Contact |
HOWARD HUTCHINSON |
Correspondent |
BOSTON PACIFIC MEDICAL, INC. |
451 D ST. |
SUITE 811 |
BOSTON,
MA
02210
|
|
Correspondent Contact |
HOWARD HUTCHINSON |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 05/21/1992 |
Decision Date | 03/25/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|