Device Classification Name |
Laparoscope, General & Plastic Surgery, Reprocessed
|
510(k) Number |
K100080 |
Device Name |
REPROCESSED TROCARS, MODEL B5LT AND CB5LT |
Applicant |
ASCENT HEALTHCARE SOLUTIONS |
10232 SOUTH 51ST ST. |
PHOENIX,
AZ
85044
|
|
Applicant Contact |
MOIRA BARTON-VARTY |
Correspondent |
ASCENT HEALTHCARE SOLUTIONS |
10232 SOUTH 51ST ST. |
PHOENIX,
AZ
85044
|
|
Correspondent Contact |
MOIRA BARTON-VARTY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/12/2010 |
Decision Date | 03/19/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|