Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K993138 |
Device Name |
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT |
Applicant |
BALLARD MEDICAL PRODUCTS |
12050 LONE PEAK PKWY. |
DRAPER,
UT
84020
|
|
Applicant Contact |
E. MARTIN CHAMBERLAIN |
Correspondent |
BALLARD MEDICAL PRODUCTS |
12050 LONE PEAK PKWY. |
DRAPER,
UT
84020
|
|
Correspondent Contact |
E. MARTIN CHAMBERLAIN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/20/1999 |
Decision Date | 10/20/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|