Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K013611 |
Device Name |
HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE |
Applicant |
HENKE SASS WOLF OF AMERICA, INC. |
203 MAIN STREET, PMB 166 |
FLEMINGTON,
NJ
08822
|
|
Applicant Contact |
LYNETTE HOWARD |
Correspondent |
HENKE SASS WOLF OF AMERICA, INC. |
203 MAIN STREET, PMB 166 |
FLEMINGTON,
NJ
08822
|
|
Correspondent Contact |
LYNETTE HOWARD |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/05/2001 |
Decision Date | 02/01/2002 |
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
|
|
|