Device Classification Name |
Endoscopic Tissue Approximation Device
|
510(k) Number |
K132362 |
Device Name |
WECK EFX ENDO FASCIAL CLOSURE SYSTEM |
Applicant |
Teleflex Medical, Inc. |
2917 WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Applicant Contact |
NATALIE HICHAK |
Correspondent |
Teleflex Medical, Inc. |
2917 WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Correspondent Contact |
NATALIE HICHAK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/30/2013 |
Decision Date | 10/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|