Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K043027 |
Device Name |
MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 |
Applicant |
APPLIED MEDICAL TECHNOLOGY, INC. |
15653 NEO PKWY. |
CLEVELAND,
OH
44128
|
|
Applicant Contact |
DEREK WILLIAMS |
Correspondent |
APPLIED MEDICAL TECHNOLOGY, INC. |
15653 NEO PKWY. |
CLEVELAND,
OH
44128
|
|
Correspondent Contact |
DEREK WILLIAMS |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 11/03/2004 |
Decision Date | 12/02/2004 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|