Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K092684 |
Device Name |
LAPAROSCOPIC RETRACTORS |
Applicant |
CARDINAL HEALTH, INC. |
1430 WAUKEGAN ROAD- MPKB-3B |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
SHARON NICHOLS |
Correspondent |
CARDINAL HEALTH, INC. |
1430 WAUKEGAN ROAD- MPKB-3B |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
SHARON NICHOLS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/01/2009 |
Decision Date | 01/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|