Device Classification Name |
pneumoperitoneum needle
|
510(k) Number |
K121370 |
Device Name |
VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE |
Applicant |
VECTEC |
2995 STEVEN MARTIN DR. |
FAIRFAX,
VA
22031
|
|
Applicant Contact |
Diane Horwitz |
Correspondent |
VECTEC |
2995 STEVEN MARTIN DR. |
FAIRFAX,
VA
22031
|
|
Correspondent Contact |
Diane Horwitz |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/07/2012 |
Decision Date | 08/02/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|