Device Classification Name |
catheter, cholangiography
|
510(k) Number |
K903709 |
Device Name |
SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH |
Applicant |
LIFESTREAM INT'L, INC. |
2828 N.CRESCENT RIVER DR. |
THE WOODLANDS,
TX
77381
|
|
Applicant Contact |
BRYAN E LYNCH |
Correspondent |
LIFESTREAM INT'L, INC. |
2828 N.CRESCENT RIVER DR. |
THE WOODLANDS,
TX
77381
|
|
Correspondent Contact |
BRYAN E LYNCH |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 08/16/1990 |
Decision Date | 10/26/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|