Device Classification Name |
Laparoscope, General & Plastic Surgery, Reprocessed
|
510(k) Number |
K053585 |
Device Name |
VANGUARD REPROCESSED SUTURE PASSER |
Applicant |
ASCENT HEALTHCARE SOLUTIONS |
10232 SOUTH 51ST ST. |
PHOENIX,
AZ
85044
|
|
Applicant Contact |
MOIRA BARTON |
Correspondent |
ASCENT HEALTHCARE SOLUTIONS |
10232 SOUTH 51ST ST. |
PHOENIX,
AZ
85044
|
|
Correspondent Contact |
MOIRA BARTON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/23/2005 |
Decision Date | 10/11/2006 |
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
|
|
|