Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K030174 |
Device Name |
GENICON LAPAROSCOPES |
Applicant |
GENICON, LC |
P.O. BOX 780038 |
ORLANDO,
FL
32878 -0038
|
|
Applicant Contact |
GARY HABERLAND |
Correspondent |
GENICON, LC |
P.O. BOX 780038 |
ORLANDO,
FL
32878 -0038
|
|
Correspondent Contact |
GARY HABERLAND |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/17/2003 |
Decision Date | 06/19/2003 |
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
|
|
|