Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K911243 |
Device Name |
CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP |
Applicant |
NORTHGATE TECHNOLOGIES, INC. |
3930 VENTURA DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Applicant Contact |
SAMUELLA D EMRICH |
Correspondent |
NORTHGATE TECHNOLOGIES, INC. |
3930 VENTURA DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Correspondent Contact |
SAMUELLA D EMRICH |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/21/1991 |
Decision Date | 06/19/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|