Device Classification Name |
filiform and filiform follower
|
510(k) Number |
K912839 |
Device Name |
LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE |
Applicant |
BAXTER HEALTHCARE CORP. |
2132 MICHELSON DR. |
IRVINE,
CA
92715
|
|
Applicant Contact |
CAROLE E MARCOT |
Correspondent |
BAXTER HEALTHCARE CORP. |
2132 MICHELSON DR. |
IRVINE,
CA
92715
|
|
Correspondent Contact |
CAROLE E MARCOT |
Regulation Number | 876.5520
|
Classification Product Code |
|
Date Received | 06/26/1991 |
Decision Date | 09/25/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|