Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K072674 |
Device Name |
KII TROCAR SYSTEM |
Applicant |
APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa |
Rancho Santa Margarita,
CA
92688
|
|
Applicant Contact |
FRANS VANDENBROEK |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFF RONGERO |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/21/2007 |
Decision Date | 10/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|