Device Classification Name |
Clip, Implantable
|
510(k) Number |
K902108 |
Device Name |
HEM-O-LOK(TM) |
Applicant |
EDWARD WECK, INC. |
P.O. BOX 12600 |
WECK DRIVE |
RESEARCH TRIANGLE PA,
NC
27709
|
|
Applicant Contact |
GLENN M MATTEI |
Correspondent |
EDWARD WECK, INC. |
P.O. BOX 12600 |
WECK DRIVE |
RESEARCH TRIANGLE PA,
NC
27709
|
|
Correspondent Contact |
GLENN M MATTEI |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 05/08/1990 |
Decision Date | 08/06/1990 |
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
|
|
|