Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K011077 |
Device Name |
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22) |
Applicant |
ANDERSEN PRODUCTS, INC. |
3202 CAROLINE DR., |
HEALTH SCIENCE PARK |
HAW RIVER,
NC
27258 -8710
|
|
Applicant Contact |
WENDY HEDRICK |
Correspondent |
ANDERSEN PRODUCTS, INC. |
3202 CAROLINE DR., |
HEALTH SCIENCE PARK |
HAW RIVER,
NC
27258 -8710
|
|
Correspondent Contact |
WENDY HEDRICK |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/09/2001 |
Decision Date | 05/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|