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510(k) K860463

SINGLE AND DUAL TOURNIQUET CUFF by Aspen Laboratories, Inc. — Product Code KCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1986
Date Received
February 6, 1986
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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  • K924960 — EXCALIBUR ELECTROSURGICAL UNIT (April 16, 1993)
  • K913213 — SINGLE USE LEE ELECTRODE (February 13, 1992)

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  • K955552 — EXPRESSAIRE TORUNIQUET SYSTEM (January 5, 1996)
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  • K954103 — TOURNI-COMP (November 1, 1995)