Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K963046 |
Device Name |
ENDOCAM |
Applicant |
CORIN U.S.A. |
10500 UNIVERSITY CENTER DR., |
SUITE 190 |
TAMPA,
FL
33612
|
|
Applicant Contact |
JACK THOMAS |
Correspondent |
CORIN U.S.A. |
10500 UNIVERSITY CENTER DR., |
SUITE 190 |
TAMPA,
FL
33612
|
|
Correspondent Contact |
JACK THOMAS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/05/1996 |
Decision Date | 11/01/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|