Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K983561 |
Device Name |
FUJINON EVL-F VIDEO LAPROSCOPE |
Applicant |
FUJINON, INC. |
399 PARK AVE. |
NEW YORK,
NY
10022 -4689
|
|
Applicant Contact |
GARY A ADLER |
Correspondent |
FUJINON, INC. |
399 PARK AVE. |
NEW YORK,
NY
10022 -4689
|
|
Correspondent Contact |
GARY A ADLER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/13/1998 |
Decision Date | 12/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|