Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K011341 |
Device Name |
LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET |
Applicant |
LH MEDICAL PRODUCTS, INC. |
301 EAST ARROW HWY., SUITE 104 |
SAN DIMAS,
CA
91773
|
|
Applicant Contact |
LONNIE HUTSON |
Correspondent |
LH MEDICAL PRODUCTS, INC. |
301 EAST ARROW HWY., SUITE 104 |
SAN DIMAS,
CA
91773
|
|
Correspondent Contact |
LONNIE HUTSON |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 05/02/2001 |
Decision Date | 09/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|