Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K121380 |
Device Name |
WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT |
Applicant |
Teleflex Medical, Inc. |
2917 WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Applicant Contact |
NATALIE SMITH |
Correspondent |
Teleflex Medical, Inc. |
2917 WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Correspondent Contact |
NATALIE SMITH |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/08/2012 |
Decision Date | 05/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|