Device Classification Name |
clip, implantable
|
510(k) Number |
K021808 |
FOIA Releasable 510(k) |
K021808
|
Device Name |
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER |
Applicant |
WECK |
2917 WECK DR. |
DURHAM,
NC
27709
|
|
Applicant Contact |
JAMES LUCKY |
Correspondent |
WECK |
2917 WECK DR. |
DURHAM,
NC
27709
|
|
Correspondent Contact |
JAMES LUCKY |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 06/03/2002 |
Decision Date | 08/14/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|