Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K100045 |
Device Name |
OCTO |
Applicant |
DALIM SURGNET CORPORATION |
300 ATWOOD |
PITTSBURGH,
PA
15213
|
|
Applicant Contact |
PETER CHUNG |
Correspondent |
DALIM SURGNET CORPORATION |
300 ATWOOD |
PITTSBURGH,
PA
15213
|
|
Correspondent Contact |
PETER CHUNG |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/08/2010 |
Decision Date | 06/25/2010 |
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
|
|
|