Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K041034 |
Device Name |
SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) |
Applicant |
ENTRACARE, LLC |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
GRACE HOLLAND |
Correspondent |
ENTRACARE, LLC |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
GRACE HOLLAND |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/21/2004 |
Decision Date | 08/31/2004 |
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
|
|
|