Device Classification Name |
Retractor
|
510(k) Number |
K043602 |
Device Name |
QUADRANT RETRACTOR SYSTEM |
Applicant |
MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
RICHARD TREHARNE |
Correspondent |
MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
RICHARD TREHARNE |
Regulation Number | 878.4800
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/29/2004 |
Decision Date | 02/23/2005 |
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
|