Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K014250 |
Device Name |
7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 |
Applicant |
GUIDANT CORP. |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
ANNE SCHLAGENHAFT |
Correspondent |
N.V. KEMA |
P.O. BOX 9035 |
6800 ET ARNHEM |
ARNHEM,
NL
|
|
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/26/2001 |
Decision Date | 01/10/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|