Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K912502 |
Device Name |
LAPAROSCOPIC LASER FIBER DIVERTER |
Applicant |
UNITED STATES ENDOSCOPY GROUP, INC. |
7123 INDUSTRIAL PARK BLVD. |
MENTOR,
OH
44060
|
|
Applicant Contact |
LISA M SCHOLZ |
Correspondent |
UNITED STATES ENDOSCOPY GROUP, INC. |
7123 INDUSTRIAL PARK BLVD. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
LISA M SCHOLZ |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/05/1991 |
Decision Date | 07/25/1991 |
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
|
|
|