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510(k) K123553

ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM by Zimmer, Inc. — Product Code KCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2013
Date Received
November 19, 2012
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

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  • K071140 — MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 (June 7, 2007)
  • K050411 — ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM (September 2, 2005)
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  • K955552 — EXPRESSAIRE TORUNIQUET SYSTEM (January 5, 1996)
  • K954201 — BUONAFEDE PNEUMATIC SLEEVE (November 9, 1995)
  • K954103 — TOURNI-COMP (November 1, 1995)
  • K953953 — DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF (September 29, 1995)