Device Classification Name |
Clip, Implantable
|
510(k) Number |
K142777 |
Device Name |
Weck Hem-o-lok Auto Endo5 Ligating Clip Applier |
Applicant |
Teleflex Medical, Inc. |
2917 Weck Drive |
Research Triangle Park,
NC
27709
|
|
Applicant Contact |
Ashlea Ricci |
Correspondent |
Teleflex Medical, Inc. |
2917 Weck Drive |
Research Triangle Park,
NC
27709
|
|
Correspondent Contact |
Ashlea Ricci |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 09/26/2014 |
Decision Date | 12/19/2014 |
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
|
|
|