Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K973891 |
Device Name |
LAPAROSCOPIC GASTROSTOMY KIT |
Applicant |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE |
BUILDING 104 |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
HOWARD V ROWE |
Correspondent |
APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE |
BUILDING 104 |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
HOWARD V ROWE |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/14/1997 |
Decision Date | 01/12/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|