Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K070712 |
Device Name |
MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM |
Applicant |
SURGICAL INNOVATIONS GROUP PLC |
CLAYTON PARK CLAYTON WOOD RISE |
LEEDS,
GB
LS16,6RF
|
|
Applicant Contact |
STUART MORAN |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
NEIL E DEVINE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/14/2007 |
Decision Date | 03/28/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|