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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tourniquet, pneumatic
510(k) Number K012632
Device Name TOURNIQUET CUFF; PNEUMATIC TOURNIQUET
Applicant
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
385 NORTH 3050 EAST
ST. GEORGE,  UT  84790
Applicant Contact JACK SPEER
Correspondent
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
385 NORTH 3050 EAST
ST. GEORGE,  UT  84790
Correspondent Contact JACK SPEER
Regulation Number878.5910
Classification Product Code
KCY  
Date Received08/13/2001
Decision Date 10/26/2001
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
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