Device Classification Name |
retractor
|
510(k) Number |
K963006 |
Device Name |
SCION SAPHENOUS VEIN HARVESTING SYSTEM |
Applicant |
SCION INTERNATIONAL, INC. |
5200 BLUE LAGOON DRIVE, |
SUITE 890 |
MIAMI,
FL
33126
|
|
Applicant Contact |
FRANK GOLDFARB |
Correspondent |
SCION INTERNATIONAL, INC. |
5200 BLUE LAGOON DRIVE, |
SUITE 890 |
MIAMI,
FL
33126
|
|
Correspondent Contact |
FRANK GOLDFARB |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 08/02/1996 |
Decision Date | 09/20/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|