Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K945862 |
Device Name |
ENDCUP |
Applicant |
LEWTEK |
13360 RIM ROCK DR. |
RENO,
NV
89511
|
|
Applicant Contact |
RAYMON A LEWIS |
Correspondent |
LEWTEK |
13360 RIM ROCK DR. |
RENO,
NV
89511
|
|
Correspondent Contact |
RAYMON A LEWIS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/01/1994 |
Decision Date | 02/23/1995 |
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
|
|
|