Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K020915 |
Device Name |
SOPRO LIGHT SOURCES AND ACCESSORIES |
Applicant |
SOPRO |
PLACE ST. CHRISTOPHE |
LES ACCATES-LA VALENTINE |
MARSEILLE,
FR
F-13011
|
|
Applicant Contact |
PIERRE MONTILLOT |
Correspondent |
SOPRO |
PLACE ST. CHRISTOPHE |
LES ACCATES-LA VALENTINE |
MARSEILLE,
FR
F-13011
|
|
Correspondent Contact |
PIERRE MONTILLOT |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/21/2002 |
Decision Date | 06/14/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|