Device Classification Name |
Clip, Implantable
|
510(k) Number |
K941972 |
Device Name |
HEMO-O-LOK |
Applicant |
KING & SPALDING |
1730 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20006 -4706
|
|
Applicant Contact |
EDWARD BASILE |
Correspondent |
KING & SPALDING |
1730 PENNSYLVANIA AVENUE, NW |
WASHINGTON,
DC
20006 -4706
|
|
Correspondent Contact |
EDWARD BASILE |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 04/22/1994 |
Decision Date | 06/29/1994 |
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
|
|
|