Device Classification Name |
tourniquet, pneumatic
|
510(k) Number |
K123553 |
Device Name |
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM |
Applicant |
ZIMMER INC. |
9001 WESLEYAN ROAD, |
SUITE 200 |
INDIANAPOLIS,
IN
46268
|
|
Applicant Contact |
ALLISON SCOTT, RAC |
Correspondent |
ZIMMER INC. |
9001 WESLEYAN ROAD, |
SUITE 200 |
INDIANAPOLIS,
IN
46268
|
|
Correspondent Contact |
ALLISON SCOTT, RAC |
Regulation Number | 878.5910
|
Classification Product Code |
|
Date Received | 11/19/2012 |
Decision Date | 08/09/2013 |
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
|
Recalls |
CDRH Recalls
|
|
|