Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K913476 |
Device Name |
GI BLEEDER/OD SET |
Applicant |
ICU MEDICAL, INC. |
142 TECHNOLOGY DR. |
IRVINE,
CA
92718
|
|
Applicant Contact |
ARACELI C FANCHER |
Correspondent |
ICU MEDICAL, INC. |
142 TECHNOLOGY DR. |
IRVINE,
CA
92718
|
|
Correspondent Contact |
ARACELI C FANCHER |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 08/05/1991 |
Decision Date | 02/12/1992 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|