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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K012614
Device Name KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN
Applicant
Medical Instruments Technology, Inc.
385 N. 3050 E.
St. George,  UT  84790
Applicant Contact JACK SPEER
Correspondent
Medical Instruments Technology, Inc.
385 N. 3050 E.
St. George,  UT  84790
Correspondent Contact JACK SPEER
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/13/2001
Decision Date 05/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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