Device Classification Name |
laparoscope, general & plastic surgery, reprocessed
|
510(k) Number |
K063788 |
Device Name |
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS |
Applicant |
ASCENT HEALTHCARE SOLUTIONS |
10232 SOUTH 51ST ST. |
PHOENIX,
AZ
85044
|
|
Applicant Contact |
KATIE BRAY |
Correspondent |
ASCENT HEALTHCARE SOLUTIONS |
10232 SOUTH 51ST ST. |
PHOENIX,
AZ
85044
|
|
Correspondent Contact |
KATIE BRAY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/21/2006 |
Decision Date | 10/15/2007 |
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
|
|
|