Device Classification Name |
Kit, Surgical Instrument, Disposable
|
510(k) Number |
K072814 |
Device Name |
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES |
Applicant |
COVIDIEN |
60 MIDDLETOWN AVE. |
NORTH HAVEN,
CT
06473
|
|
Applicant Contact |
ROBERT ZOTT |
Correspondent |
COVIDIEN |
60 MIDDLETOWN AVE. |
NORTH HAVEN,
CT
06473
|
|
Correspondent Contact |
ROBERT ZOTT |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 10/01/2007 |
Decision Date | 04/16/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|