Device Classification Name |
Clip, Implantable
|
510(k) Number |
K973652 |
Device Name |
DUOCLIPPER TITANIUM CLIPS |
Applicant |
SCION INTERNATIONAL, INC. |
5200 BLUE LAGOON DRIVE, |
SUITE 890 |
MIAMI,
FL
33126
|
|
Applicant Contact |
STEPHEN CHAKOFF |
Correspondent |
SCION INTERNATIONAL, INC. |
5200 BLUE LAGOON DRIVE, |
SUITE 890 |
MIAMI,
FL
33126
|
|
Correspondent Contact |
STEPHEN CHAKOFF |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 09/25/1997 |
Decision Date | 03/27/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|