510(k) K050411

ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM by Zimmer, Inc. — Product Code KCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2005
Date Received
February 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Pneumatic
Device Class
Class I
Regulation Number
878.5910
Review Panel
SU
Submission Type